BioequivalencePhase 1NCT05940909
Bioequivalence Study of Perindopril /Amlodipine/Indapamide 8 mg (10 mg)/2.5 mg/10 mg Tablets in Healthy Volunteers Under Fasting Conditions
A Phase 1 study testing Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Russia.
Trial summary
This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Triplixam®, 10 mg/2.5 mg/10 mg tablets) or the test (Perindopril Erbumine/ 8 mg/2.5 mg/10 mg Tablets) formulation in each period of study (sequences… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 24 Jun 2023to 17 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy european men or women aged between 18 to 45 years
- Body mass index 18.5-30 kg/m² according to Quetelet's weight-height index
- Verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods, physical examination and anamnestic examination
- The level of systolic blood pressure (SBP) measured in the sitting position at the time of screening ≥100 mm Hg and ≤ 139 mm Hg and diastolic blood pressure (DBP) ≥ 60 mm Hg or ≤ 90 mm Hg; heart rate more than 60 beats/min and less than 90 beats/min at the time of screening, respiratory rate more than 12 and less than 20 per minute at the time of screening, body temperature above 35.9 ° C and below 36.9 °C at the time of screening
- Subjects are able to understand the requirements of the study
- Subjects are able to accept all the restrictions imposed during the course of the study
Show all 14Show fewer
- The written consent of the volunteer to be included in the study
- For female subject:
- negative pregnancy test;
- adherence to reliable methods of contraception for female of childbearing potential: sexual continence, or condom + spermicide, or diaphragm + spermicide, started at least 14 days before the first dose of the study drug; intrauterine contraception is also a reliable method of contraception, installed at least 4 weeks before taking the study drugs in the first period;
- сonsent to use these methods of contraception within 30 days after taking the drug in the second period;
- women who do not use acceptable methods of contraception, if they are considered incapable of childbearing, will also be able to participate in the study: women who have undergone a hysterectomy or tubal ligation, women with a clinical diagnosis of infertility, and women who are in menopause (at least a year without menstruation in the absence of alternative pathologies that may cause the cessation of menstruation);
- in case of using contraceptives (injectable and oral hormonal contraceptives, subcutaneous hormonal implants or intrauterine hormonal therapeutic systems), the latter should be canceled at least 60 days before taking the drug in the first period;
- For male: consent to use a double barrier method of contraception (condom + spermicide) or complete sexual abstinence, as well as consent not to participate in sperm donation during the entire study and 30 days after taking the drug in the second period.
Who cannot join
- hypersensitivity to perindopril or any ACE inhibitors, amlodipine, indapamide or excipients that are part of any of the investigational drugs, or intolerance to these components;
- burdened allergic history
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- acute infectious diseases or allergic diseases that ended less than 4 weeks before taking the drug in the first period;
- surgical interventions on the gastrointestinal tract, with the exception of appendectomy
- clinically significant pathologies of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys and blood;
Show all 30Show fewer
- the value of standard laboratory and instrumental parameters that go beyond the reference values
- positive test for syphilis, hepatitis B, hepatitis C or HIV at the time of screening;
- positive test for alcohol in exhaled air at screening
- positive urine analysis for the content of narcotic and potent substances during screening (opiates, morphine, barbiturates, benzodiazepines, cannabinoids/marijuana)
- for women - positive pregnancy test at screening
- adherence to any low-sodium diet within 2 weeks prior to taking the drug in the first study period, or adherence to a special diet (vegetarian, vegan, salt-restricted)
- intake of more than 10 units alcohol per week (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of dry wine or 50 ml of spirits ethyl 40%) or history of alcoholism, drug addiction, drug abuse;
- inability to go without food for at least 12 hours and the inability to take the drug on an empty stomach;
- donation of plasma or blood (450 ml or more) less than 3 months before taking the drug in the first period;
- the use of injectable and oral hormonal contraceptives for 60 days before taking the drug in the first period;
- the use of subcutaneous hormonal implants or intrauterine hormonal therapeutic systems for 6 months before taking the drug in the first period;
- use of any prescription and OTC drugs less than 2 weeks before the screening
- use of well-known inducers of liver microsomal enzymes (barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.) inhibitors of liver microsomal enzymes (antidepressants, cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines), vitamins, herbs and food additives (cat's claw, angelica officinalis, oenothera, pyrethrum, garlic, ginger, ginkgo, red clover, horse chestnut, green tea, ginseng; St. john's wort etc.) less than 30 days before enrollement in the study
- for women: volunteers with preserved reproductive potential who had unprotected sexual intercourse with an unsterilized male partner within 30 days before the first day of screening;
- breastfeeding;
- participation in other clinical trials of drugs less than 3 months before the screening;
- difficulty with taking blood;
- smoking
- volunteers who are unwilling or unable to give up alcohol and excessive physical activity from the first day of screening until the follow-up visit;
- consumption of caffeine and xanthine-containing drinks and products (tea, coffee, chocolate, cola, etc.), products containing poppy seeds and use of citrus fruits (including grapefruit and grapefruit juice) from the first day of screening until the follow-up visit;
- intense physical activity or following lifestyle (night work, extreme physical activity)
- lack of intention of volunteers to comply with the Protocol requirements throughout the course of the study and/or lack, in the opinion of the Investigator, of the volunteers' ability to understand and evaluate the information on this study as part of the informed consent form signing process, in particular regarding the expected risks and possible discomfort;
- dehydration due to diarrhea, vomiting or other reason within the last 24 hours before taking the drug in the first period of the study;
- the presence of seizures, epilepsy and any other neurological disorders in the history of volunteers
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Ligand Research LLC
Moscow, 109235
Sergey Filatov, +7 916 222 44 20, sergey.filatov@ligand-research.com
Irina Rodyukova
About this study
Official title: Open-label Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations of Perindopril Erbumine/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg Tablets (Pharmtechnology LLC, Republic of Belarus) and Triplixam® 10 mg/2.5 mg/10 mg Tablets (Les Laboratoires Servier Industrie, France) in Healthy Volunteers Under Fasting Conditions
This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Triplixam®, 10 mg/2.5 mg/10 mg tablets) or the test (Perindopril Erbumine/ 8 mg/2.5 mg/10 mg Tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
Read the detailed description
This is an open-labeled, randomized, two period, crossover, a single-center, comparative, single-dose study, in which 50 healthy adult subjects will receive one of the study treatments during each study period.
The objective of this study is to determine the bioequivalence of two different formulations of Perindopril/ Indapamide/Amlodipine after a single oral dose administration under fasting conditions.
Subject eligibility for this study will be determined at the screening visit and eligible subjects will be admitted to the clinical research unit at least 12 hours prior to drug administration for each study period.
Hospitalization in the first period of the study will last no more than 36 hours, after which, in the absence of indications for an extension of hospitalization, each subject will be released home; after that, the first period of the study will be completed.
The procedures of the second study period will be identical to the first period.
After completing all the procedures of the second study period, each subject will undergo a final examination, after which, in case of the absence of adverse events and indications for prolonging hospitalization, the study for the subjects will be considered completed.
The total duration of the study for the subject will be no more than 54 days.
Eligible subjects will be randomized to one of two treatment sequences. There will be two sequences in the study: TR and RT, where T = the test product, R = the reference product.
For each study period, subjects will receive a single oral dose of perindopril/amlodipine/indapamide (the test or the reference formulation). Study participants will be aware they will receive different formulations of the same drug, without being informed which product (Test or Reference) is being administered. For each subject, all scheduled postdose activities and assessments will be performed relative to the time of study drug administration.
Fasting will continue for at least 4 hours following drug administration, after which a standardized lunch will be served. Next meals will be provided for subjects in 4 hours, 8 hours and 12 hours after drug administration.
Water will be provided as needed until 1 hour predose. Water will be allowed beginning 2 hours after the administration of the drug.
A total of 29 blood samples will be collected (one tube of 5-10 mL each) in each study period for pharmacokinetic (PK) assessments. The first blood sample will be collected prior to drug administration while the others will be collected up to 72 hours after drug administration.
Perindopril, perindoprilate, amlodipine plasma concentrations and indapamide whole blood concentrations will be measured according to a validated bioanalytical method.
Statistical analysis of all PK parameters will be based on an ANOVA model. Two-sided 90% confidence interval of the ratio of geometric LSmeans obtained from the ln-transformed PK parameters will be calculated.
Statistical inference of perindopril, perindoprilate, amlodipine and indapamide will be based on a bioequivalence approach using the following standards: the ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the Test and the Reference for the ln-transformed parameters Cmax and AUC0-t should all be within the 80.00 to 125.00% bioequivalence range.
- Conditions
- Bioequivalence
- Being tested
- Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet
- Keywords
- Perindopril, Perindoprilate, Amlodipine, Indapamide, Triplixam, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tabletDrug
Also called The test product / The reference product
Perindopril/Indapamide/Amlodipine is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 8 mg of perindopril erbumine, 2.5 mg of indapamide and 10 mg of amlodipine.
Triplixam® is manufactured by Les Laboratoires Servier Industrie, France. Each tablet contains 10 mg of perindopril arginine, 2.5 mg of indapamide and 10 mg of amlodipine.
| Study group | Role | What they receive |
|---|---|---|
| Sequence TR | Other | 25 subjects assigned to the sequence TR will receive a single oral dose of the test product Perindopril Erbumine/Indapamide/Amlodipine (1 x 8 mg/2.5 mg/10 mg tablet), marked as T in the sequence, in Period 1 and a single oral dose of the reference product Triplixam® (1 x 10 mg/2.5 mg/10 mg tablet), marked as R in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet |
| Sequence RT | Other | 25 subjects assigned to the sequence RT will receive a single oral dose of the reference product Triplixam® (1 x 10 mg/2.5 mg/10 mg tablet), marked as R in the sequence, in Period 1 and a single oral dose of the test product Perindopril Erbumine/Amlodipine/Indapamide (1 x 8 mg/2.5 mg/10 mg tablet), marked as T in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of perindopril after administration of the test and the reference products.
Maximum observed concentration in plasma.
Measured: Time points for perindopril 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 hours after each drug administration.
Cmax of active metabolite perindoprilat of the test and the reference products
Maximum observed concentration in plasma.
Measured: Time points for perindoprilat 0.00 (prior to each drug administration) and 0.30, 1.00, 1.30, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 5.30, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Cmax of indapamide of the test and the reference products
Maximum observed concentration in plasma.
Measured: Time points for indapamide 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Cmax of amlodipine of the test and the reference products
Maximum observed concentration in plasma.
Measured: Time points for amlodipine 0.00 (prior to each drug administration) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
AUC0-72 of perindopril of the test and reference products
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
Measured: Time points for perindopril 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 hours after each drug administration.
AUC0-72 of active metabolite perindoprilat of the test and reference products
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
Measured: Time points for perindoprilat 0.00 (prior to each drug administration) and 0.30, 1.00, 1.30, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 5.30, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
AUC0-72 of indapamide of the test and reference products
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
Measured: Time points for indapamide 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
AUC0-72 of amlodipine of the test and reference products
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
Measured: Time points for amlodipine 0.00 (prior to each drug administration) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Secondary outcomes (8)
Tmax of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Time of maximum observed concentration. if it occurs at more than one time point, Tmax is defined as the first time point with this value.
Measured: Up to 72 hours
TLQC of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Time of last observed quantifiable concentration.
Measured: Up to 72 hours
AUC0-INF of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Area under the concentration time curve extrapolated to infinity, calculated as AUC0-t + ĈLQC (the predicted concentration at time TLQC) / λZ (apparent elimination rate constant).
Measured: Up to 72 hours
Residual area of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Extrapolated area (i.e. percentage of AUC0-INF due to extrapolation from TLQC to infinity).
Measured: Up to 72 hours
Time point where the log-linear elimination phase begins (TLIN) of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood
Time point where the log-linear elimination phase begins.
Measured: Up to 72 hours
λZ of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve.
Measured: Up to 72 hours
Terminal elimination half-life (Thalf) of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Terminal elimination half-life, calculated as ln(2)/λZ.
Measured: Up to 72 hours
Number of treatment-emergent adverse events for the test and the reference products.
The safety population will include all subjects who received at least one dose of the test or the reference product. Any significant changes will be recorded as treatment-emergent adverse events only if they are judged clinically significant by the qualified investigator or delegate.
Measured: Up to 54 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start24 Jun 2023
- Primary completion17 Aug 2023 (estimated)
- Study completion17 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmtechnology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irina Rodyukova, Principal investigator, Ligand Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940909
- Sponsor's protocol ID
- PIA_PT_01
- Status last verified
- Jul 2023
- First submitted
- 26 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations of Perindopril Erbumine/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg Tablets (Pharmtechnology LLC, Republic of Belarus) and Triplixam® 10 mg/2.5 mg/10 mg Tablets (Les Laboratoires Servier Industrie, France) in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05940909
- Acronym / sponsor ID
- PIA_PT_01
- Conditions
- Bioequivalence
- Keywords
- Perindopril, Perindoprilate, Amlodipine, Indapamide, Triplixam, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pharmtechnology LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2023 (actual)
- Primary completion
- 17 Aug 2023 (estimated)
- Study completion
- 17 Nov 2023 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Triplixam®, 10 mg/2.5 mg/10 mg tablets) or the test (Perindopril Erbumine/ 8 mg/2.5 mg/10 mg Tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
Detailed description
This is an open-labeled, randomized, two period, crossover, a single-center, comparative, single-dose study, in which 50 healthy adult subjects will receive one of the study treatments during each study period.
The objective of this study is to determine the bioequivalence of two different formulations of Perindopril/ Indapamide/Amlodipine after a single oral dose administration under fasting conditions.
Subject eligibility for this study will be determined at the screening visit and eligible subjects will be admitted to the clinical research unit at least 12 hours prior to drug administration for each study period.
Hospitalization in the first period of the study will last no more than 36 hours, after which, in the absence of indications for an extension of hospitalization, each subject will be released home; after that, the first period of the study will be completed.
The procedures of the second study period will be identical to the first period.
After completing all the procedures of the second study period, each subject will undergo a final examination, after which, in case of the absence of adverse events and indications for prolonging hospitalization, the study for the subjects will be considered completed.
The total duration of the study for the subject will be no more than 54 days.
Eligible subjects will be randomized to one of two treatment sequences. There will be two sequences in the study: TR and RT, where T = the test product, R = the reference product.
For each study period, subjects will receive a single oral dose of perindopril/amlodipine/indapamide (the test or the reference formulation). Study participants will be aware they will receive different formulations of the same drug, without being informed which product (Test or Reference) is being administered. For each subject, all scheduled postdose activities and assessments will be performed relative to the time of study drug administration.
Fasting will continue for at least 4 hours following drug administration, after which a standardized lunch will be served. Next meals will be provided for subjects in 4 hours, 8 hours and 12 hours after drug administration.
Water will be provided as needed until 1 hour predose. Water will be allowed beginning 2 hours after the administration of the drug.
A total of 29 blood samples will be collected (one tube of 5-10 mL each) in each study period for pharmacokinetic (PK) assessments. The first blood sample will be collected prior to drug administration while the others will be collected up to 72 hours after drug administration.
Perindopril, perindoprilate, amlodipine plasma concentrations and indapamide whole blood concentrations will be measured according to a validated bioanalytical method.
Statistical analysis of all PK parameters will be based on an ANOVA model. Two-sided 90% confidence interval of the ratio of geometric LSmeans obtained from the ln-transformed PK parameters will be calculated.
Statistical inference of perindopril, perindoprilate, amlodipine and indapamide will be based on a bioequivalence approach using the following standards: the ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the Test and the Reference for the ln-transformed parameters Cmax and AUC0-t should all be within the 80.00 to 125.00% bioequivalence range.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence TR | Other | Drug: Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet25 subjects assigned to the sequence TR will receive a single oral dose of the test product Perindopril Erbumine/Indapamide/Amlodipine (1 x 8 mg/2.5 mg/10 mg tablet), marked as T in the sequence, in Period 1 and a single oral dose of the reference product Triplixam® (1 x 10 mg/2.5 mg/10 mg tablet), marked as R in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence RT | Other | Drug: Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet25 subjects assigned to the sequence RT will receive a single oral dose of the reference product Triplixam® (1 x 10 mg/2.5 mg/10 mg tablet), marked as R in the sequence, in Period 1 and a single oral dose of the test product Perindopril Erbumine/Amlodipine/Indapamide (1 x 8 mg/2.5 mg/10 mg tablet), marked as T in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy european men or women aged between 18 to 45 years
- Body mass index 18.5-30 kg/m² according to Quetelet's weight-height index
- Verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods, physical examination and anamnestic examination
- The level of systolic blood pressure (SBP) measured in the sitting position at the time of screening ≥100 mm Hg and ≤ 139 mm Hg and diastolic blood pressure (DBP) ≥ 60 mm Hg or ≤ 90 mm Hg; heart rate more than 60 beats/min and less than 90 beats/min at the time of screening, respiratory rate more than 12 and less than 20 per minute at the time of screening, body temperature above 35.9 ° C and below 36.9 °C at the time of screening
- Subjects are able to understand the requirements of the study
Key exclusion criteria (30 listed)
- hypersensitivity to perindopril or any ACE inhibitors, amlodipine, indapamide or excipients that are part of any of the investigational drugs, or intolerance to these components;
- burdened allergic history
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- acute infectious diseases or allergic diseases that ended less than 4 weeks before taking the drug in the first period;
- surgical interventions on the gastrointestinal tract, with the exception of appendectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tabletAlso: The test product / The reference productPerindopril/Indapamide/Amlodipine is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 8 mg of perindopril erbumine, 2.5 mg of indapamide and 10 mg of amlodipine. Triplixam® is manufactured by Les Laboratoires Servier Industrie, France. Each tablet contains 10 mg of perindopril arginine, 2.5 mg of indapamide and 10 mg of amlodipine. | Drug | Sequence RT, Sequence TR |
Primary outcome
Cmax of perindopril after administration of the test and the reference products.
Time frame: Time points for perindopril 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 hours after each drug administration.
Maximum observed concentration in plasma.
Cmax of active metabolite perindoprilat of the test and the reference products
Time frame: Time points for perindoprilat 0.00 (prior to each drug administration) and 0.30, 1.00, 1.30, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 5.30, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Maximum observed concentration in plasma.
Cmax of indapamide of the test and the reference products
Time frame: Time points for indapamide 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Maximum observed concentration in plasma.
Cmax of amlodipine of the test and the reference products
Time frame: Time points for amlodipine 0.00 (prior to each drug administration) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Maximum observed concentration in plasma.
AUC0-72 of perindopril of the test and reference products
Time frame: Time points for perindopril 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 hours after each drug administration.
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
AUC0-72 of active metabolite perindoprilat of the test and reference products
Time frame: Time points for perindoprilat 0.00 (prior to each drug administration) and 0.30, 1.00, 1.30, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 5.30, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
AUC0-72 of indapamide of the test and reference products
Time frame: Time points for indapamide 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
AUC0-72 of amlodipine of the test and reference products
Time frame: Time points for amlodipine 0.00 (prior to each drug administration) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
8 secondary outcomes
Tmax of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Time frame: Up to 72 hours
TLQC of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Time frame: Up to 72 hours
AUC0-INF of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Time frame: Up to 72 hours
Residual area of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Time frame: Up to 72 hours
Time point where the log-linear elimination phase begins (TLIN) of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood
Time frame: Up to 72 hours
λZ of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Time frame: Up to 72 hours
Terminal elimination half-life (Thalf) of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Time frame: Up to 72 hours
Number of treatment-emergent adverse events for the test and the reference products.
Time frame: Up to 54 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
Related trials for Bioequivalence
Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
Active, not recruitingPhase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina Rodyukova principal investigator
Ligand Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Poklad (80173094418, specialist.fs@ft.by), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of perindopril after administration of the test and the reference products. (time frame: Time points for perindopril 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 hours after each drug administration.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.