BioequivalencePhase 1NCT05339373
Bioequivalence Study of Two Formulations of Tablets Aceclofenac 100 mg in Healthy Volunteers Under Fasting Conditions
A Phase 1 study testing Aceclofenac film-coated tablet 100 mg and Airtal® film-coated tablet 100 mg in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Russia.
Trial summary
This is an open-label, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Airtal ®, 100 mg film-coated tablets) or the test (Aceclofenac, 100 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR)… 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?
- Aceclofenac film-coated tablet 100 mg and Airtal® film-coated tablet 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteRussia
- Study dates
- 15 Apr 2022to 15 Aug 2022
- 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
- The written consent of the volunteer to be included in the study
- 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 results of an X-ray or fluorographic examination of the chest organs within the normal range (the results of an examination carried out within 12 months before the start of the study may be provided)
- Body mass index 18.5-30 kg/m² according to Quetelet's weight-height index
- For female:
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- the results of the examination of the mammary glands (palpation or mammography) within the normal range according to the data obtained within 12 months before the start of the study;
- non-breastfeeding women;
- 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.
- Subjects are able to understand the requirements of the study, to sign a written informed consent, and also to accept all the restrictions imposed during the course of the study, and to agree to return for the required investigations.
Who cannot join
- burdened allergic history, hypersensitivity to any ACE inhibitors, including aceclofenac or excipients that are part of any of the investigational drugs, or intolerance to these components;
- bronchospasm, urticaria, rhinitis after taking acetylsalicylic acid or other NSAIDs in history (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
- bleeding or perforation of the gastrointestinal tract associated with the use of NSAIDs in history;
- acute bleeding or diseases accompanied by bleeding in the last 2 months;
- clinically significant pathologies of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys and blood;
- other diseases that, in the opinion of the researcher, may affect the absorption, distribution, metabolism or excretion of both drugs, or increase the risk of negative consequences for the volunteer;
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- the presence of mental disorders, including a history;
- surgical interventions on the gastrointestinal tract, with the exception of appendectomy;
- acute infectious diseases that ended less than 4 weeks before taking the drug in the first period;
- dehydration due to diarrhea, vomiting or other reason within the last 24 hours before taking the drug in the first period of the study;
- clinically significant abnormalities on the ECG, the level of systolic blood pressure (SBP) measured in the sitting position at the time of screening ≤ 100 mm Hg or ≥ 139 mm Hg and / or diastolic blood pressure (DBP) ≤ 70 mm Hg or ≥ 89 mm Hg;
- heart rate less than 60 beats/min or more than 90 beats/min at the time of screening, respiratory rate less than 12 or more than 18 per minute at the time of screening, body temperature below 36.0 ° C or above 37.0 °C at the time of screening;
- the use of injectable and oral hormonal contraceptives, subcutaneous hormonal implants or intrauterine hormonal therapeutic systems and other hormonal contraceptives for 60 days before taking the drug in the first period;
- use of any drugs including herbs and food additives, vitamins that can have a significant effect on the PK of lisinopril or data on the effect of which on the pharmacokinetics of lisinopril are unknown, as well as question the characterization of the volunteer as healthy, less than 14 days before taking the drug in the first period;
- taking known inhibitors or inducers of microsomal liver enzymes (barbiturates, omeprazole, cimetidine, etc.) or antiviral drugs less than 2 months before taking the drug in the first study period;
- donation of plasma or blood (450 ml or more) less than 2 months before taking the drug in the first period;
- 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) or lifestyle (night work, extreme physical exercise);
- consumption of caffeine and xanthine-containing drinks and products (tea, coffee, chocolate, cola, etc.), products containing poppy seeds, less than 48 hours before taking the drug in the first period;
- consumption of alcohol and alcohol-containing foods and beverages less than 48 hours before taking the drug in the first period;
- use of citrus fruits (including grapefruit and grapefruit juice) and cranberries (including juices, fruit drinks, etc.) less than 7 days before taking the drug in the first period;
- 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 refrain from intensive physical activity and contact sports less than 24 hours before taking the drug in the first period;
- smoking more than 10 cigarettes per day less than 24 hours before taking the drug in the first period;
- participation in other clinical trials of drugs less than 3 months before taking the drug in the first period;
- test positive for syphilis, hepatitis B, hepatitis C or HIV at the time of screening;
- positive pregnancy test at screening;
- breastfeeding;
- positive test for alcohol in exhaled air at screening;
- positive urinalysis for the content of narcotic and potent substances during screening (opiates, morphine, barbiturates, benzodiazepines, cannabinoids/marijuana);
- the value of standard laboratory and instrumental parameters that go beyond the reference values;
- 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;
- mental, physical and other reasons that do not allow the subject to adequately assess their behavior and correctly fulfill the conditions of the Research Protocol;
- tattooing and piercing within 30 days prior to first drug administration;
- difficulty swallowing tablets;
- difficulty with taking blood;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations Aceclofenac Tablets 100 mg (Pharmtechnology LLC, Republic of Belarus) and Airtal® Tablets 100 mg (Gedeon Richter- RUS", Russia / Gedeon Richter, Hungary; MA Holder: Almiral S.A., Spain) in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Airtal ®, 100 mg film-coated tablets) or the test (Aceclofenac, 100 mg film-coated 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 36 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 aceclofenac 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 37 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 22 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 100 mg oral dose of aceclofenac (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 6 hours, 9 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 20 blood samples will be collected (one tube of 6 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 24 hours after drug administration.
Aceclofenac plasma 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 aceclofenac 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
- Aceclofenac film-coated tablet 100 mg, Airtal® film-coated tablet 100 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aceclofenac film-coated tablet 100 mgDrug
Also called The test product
Aceclofenac is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 100 mg of aceclofenac.
Airtal® film-coated tablet 100 mgDrug
Also called The reference product
Airtal ® is manufactured by Gedeon Richter- RUS", Russia / Gedeon Richter, Hungary. Each tablet contains 100 mg of aceclofenac.
| Study group | Role | What they receive |
|---|---|---|
| Sequence TR | Other | 18 subjects assigned to the sequence TR will receive a single 100 mg dose of the test product Aceclofenac (1 x 100 mg tablet), marked as T in the sequence, in Period 1 and a single 100 mg dose of the reference product Airtal ® (1 x 100 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: Aceclofenac film-coated tablet 100 mg; Drug: Airtal® film-coated tablet 100 mg |
| Sequence RT | Other | 18 subjects assigned to the sequence RT will receive a single 100 mg dose of the test product Airtal ® (1 x 100 mg tablet), marked as R in the sequence, in Period 1 and a single 100 mg dose of thetest product Aceclofenac (1 x 100 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: Aceclofenac film-coated tablet 100 mg; Drug: Airtal® film-coated tablet 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of aceclofenac in plasma after administration of the test and the reference products.
Maximum observed concentration in plasma.
Measured: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
AUC0-t of aceclofenac in plasma after administration of the test and the reference.
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration using the linear trapezoidal method.
Measured: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Secondary outcomes (8)
Tmax of aceclofenac in plasma 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: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
TLQC of aceclofenac in plasma after administration of the test and the reference products.
Time of last observed quantifiable concentration.
Measured: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
AUC0-INF of aceclofenac in plasma 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: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Residual area of aceclofenac in plasma 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: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Time point where the log-linear elimination phase begins (TLIN) of aceclofenac in plasma after administration of the test and the reference. products.
Time point where the log-linear elimination phase begins.
Measured: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
λZ of aceclofenac in plasma 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: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Terminal elimination half-life (Thalf) of aceclofenac in plasma after administration of the test and the reference products.
Terminal elimination half-life, calculated as ln(2)/λZ.
Measured: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
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: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start15 Apr 2022
- Primary completion30 Apr 2022
- Study completion15 Aug 2022
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmtechnology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- X7 Clinical Research LLC
- Responsible party
- Sponsor
- Investigators
- Evgenia Simonova, Principal investigator, CRO X7 Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339373
- Sponsor's protocol ID
- ACFNC-2021
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 28 Jun 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 28 Jun 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 Aceclofenac Tablets 100 mg (Pharmtechnology LLC, Republic of Belarus) and Airtal® Tablets 100 mg (Gedeon Richter- RUS", Russia / Gedeon Richter, Hungary; MA Holder: Almiral S.A., Spain) in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05339373
- Acronym / sponsor ID
- ACFNC-2021
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pharmtechnology LLCIndustry (pharma, biotech, devices)
- Collaborators
- X7 Clinical Research LLC
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 21 Apr 2022 (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-label, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Airtal ®, 100 mg film-coated tablets) or the test (Aceclofenac, 100 mg film-coated 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 36 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 aceclofenac 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 37 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 22 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 100 mg oral dose of aceclofenac (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 6 hours, 9 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 20 blood samples will be collected (one tube of 6 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 24 hours after drug administration.
Aceclofenac plasma 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 aceclofenac 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: Aceclofenac film-coated tablet 100 mg, Drug: Airtal® film-coated tablet 100 mg18 subjects assigned to the sequence TR will receive a single 100 mg dose of the test product Aceclofenac (1 x 100 mg tablet), marked as T in the sequence, in Period 1 and a single 100 mg dose of the reference product Airtal ® (1 x 100 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: Aceclofenac film-coated tablet 100 mg, Drug: Airtal® film-coated tablet 100 mg18 subjects assigned to the sequence RT will receive a single 100 mg dose of the test product Airtal ® (1 x 100 mg tablet), marked as R in the sequence, in Period 1 and a single 100 mg dose of thetest product Aceclofenac (1 x 100 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 (15 listed)
- Healthy european men or women aged between 18 to 45 years
- The written consent of the volunteer to be included in the study
- 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 results of an X-ray or fluorographic examination of the chest organs within the normal range (the results of an examination carried out within 12 months before the start of the study may be provided)
- Body mass index 18.5-30 kg/m² according to Quetelet's weight-height index
Key exclusion criteria (35 listed)
- burdened allergic history, hypersensitivity to any ACE inhibitors, including aceclofenac or excipients that are part of any of the investigational drugs, or intolerance to these components;
- bronchospasm, urticaria, rhinitis after taking acetylsalicylic acid or other NSAIDs in history (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
- bleeding or perforation of the gastrointestinal tract associated with the use of NSAIDs in history;
- acute bleeding or diseases accompanied by bleeding in the last 2 months;
- clinically significant pathologies of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys and blood;
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 |
|---|---|---|
| Aceclofenac film-coated tablet 100 mgAlso: The test productAceclofenac is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 100 mg of aceclofenac. | Drug | Sequence RT, Sequence TR |
| Airtal® film-coated tablet 100 mgAlso: The reference productAirtal ® is manufactured by Gedeon Richter- RUS", Russia / Gedeon Richter, Hungary. Each tablet contains 100 mg of aceclofenac. | Drug | Sequence RT, Sequence TR |
Primary outcome
Cmax of aceclofenac in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Maximum observed concentration in plasma.
AUC0-t of aceclofenac in plasma after administration of the test and the reference.
Time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration using the linear trapezoidal method.
8 secondary outcomes
Tmax of aceclofenac in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
TLQC of aceclofenac in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
AUC0-INF of aceclofenac in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Residual area of aceclofenac in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Time point where the log-linear elimination phase begins (TLIN) of aceclofenac in plasma after administration of the test and the reference. products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
λZ of aceclofenac in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Terminal elimination half-life (Thalf) of aceclofenac in plasma after administration of the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Number of treatment-emergent adverse events for the test and the reference products.
Time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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.
Evgenia Simonova principal investigator
CRO X7 Clinical Research
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 Aceclofenac film-coated tablet 100 mg and Airtal® film-coated tablet 100 mg 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 15 inclusion and 35 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: finished, as of the sponsor's last update on 28 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of aceclofenac in plasma after administration of the test and the reference products. (time frame: Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.). The study lists 2 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 28 Jun 2023.