BioequivalencePhase 1NCT05464745
Bioequivalence Study of 8 mg Perindopril Tert-butylamine / 2.5 mg Indapamide Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide Film-coated Tablets in Healthy Volunteers
A Phase 1 study testing PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets and Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets in people with Bioequivalence and Healthy Subjects, run by Darnitsa Pharmaceutical Company at 1 site in Jordan.
Trial summary
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® DUO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence, Healthy Subjects
- What is being tested?
- PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets and Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteJordan
- Study dates
- 19 May 2021to 9 Jun 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects, age 18 to 50 years, inclusive, body mass index (BMI) range is within 18.5 - 30.0 kg/m2, subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs, standard ECG assessment is normal (no QTc prolongation), medical history and physical examination within medically acceptable criteria, laboratory investigations tests within laboratory reference ranges (ALP and creatinine are accepted if below 5% of the reference range). Haematology tests within 5% of reference limits, the subject is willing to adhere to the protocol requirement throughout the study and to provide written informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® DUO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") and Reference Product Noliterax® 10 mg /2.5 mg, 10 mg Perindopril Arginine / 2.5 mg Indapamide Film-Coated Tablets (Manufactured By Servier (Ireland) Industries Ltd) In Healthy, Adult Subjects Under Fasting Conditions
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® DUO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product Noliterax® 10 mg /2.5 mg, 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets [manufactured by Servier (Ireland) Industries Ltd]) in healthy volunteers.
- Conditions
- Bioequivalence, Healthy Subjects
- Being tested
- PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets, Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets
- Keywords
- bioequivalence, perindopril, indapamide, healthy subjects, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tabletsDrug
Oral, generic fixed-dose combination of perindopril tert-butylamine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure)
Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tabletsDrug
Oral, innovative fixed-dose combination of perindopril arginine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure)
| Study group | Role | What they receive |
|---|---|---|
| PERINDOPRES® DUO (Test) | Experimental | A single oral dose of the test product PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets. Receives: Drug: PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets |
| Noliterax® 10 mg/2.5 mg (Reference) | Active comparator | A single oral dose of the reference product Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets. Receives: Drug: Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of perindopril
The Cmax values are based on perindopril plasma concentration.
Measured: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of perindopril
The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on perindopril plasma concentration.
Measured: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose
Cmax of indapamide
The Cmax values are based on indapamide plasma concentration.
Measured: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose
AUC0-t of indapamide
The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on indapamide plasma concentration.
Measured: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start19 May 2021
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
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
- Model description
- Two-period, two-sequence, cross-over single dose study
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darnitsa Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Pharmaceutical Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464745
- Sponsor's protocol ID
- PER03-E
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® DUO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") and Reference Product Noliterax® 10 mg /2.5 mg, 10 mg Perindopril Arginine / 2.5 mg Indapamide Film-Coated Tablets (Manufactured By Servier (Ireland) Industries Ltd) In Healthy, Adult Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05464745
- Acronym / sponsor ID
- PER03-E
- Conditions
- Bioequivalence, Healthy Subjects
- Keywords
- bioequivalence, perindopril, indapamide, healthy subjects, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Darnitsa Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Collaborators
- International Pharmaceutical Research Center
- Study start
- 19 May 2021 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 19 Jul 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.
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® DUO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product Noliterax® 10 mg /2.5 mg, 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets [manufactured by Servier (Ireland) Industries Ltd]) in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-period, two-sequence, cross-over single dose study
| Arm | Type | Receives |
|---|---|---|
| PERINDOPRES® DUO (Test) | Experimental | Drug: PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tabletsA single oral dose of the test product PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets. |
| Noliterax® 10 mg/2.5 mg (Reference) | Active comparator | Drug: Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tabletsA single oral dose of the reference product Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects, age 18 to 50 years, inclusive, body mass index (BMI) range is within 18.5 - 30.0 kg/m2, subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs, standard ECG assessment is normal (no QTc prolongation), medical history and physical examination within medically acceptable criteria, laboratory investigations tests within laboratory reference ranges (ALP and creatinine are accepted if below 5% of the reference range). Haematology tests within 5% of reference limits, the subject is willing to adhere to the protocol requirement throughout the study and to provide written informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tabletsOral, generic fixed-dose combination of perindopril tert-butylamine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) | Drug | PERINDOPRES® DUO (Test) |
| Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tabletsOral, innovative fixed-dose combination of perindopril arginine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) | Drug | Noliterax® 10 mg/2.5 mg (Reference) |
Primary outcome
Maximum plasma concentration (Cmax) of perindopril
Time frame: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose
The Cmax values are based on perindopril plasma concentration.
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of perindopril
Time frame: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose
The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on perindopril plasma concentration.
Cmax of indapamide
Time frame: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose
The Cmax values are based on indapamide plasma concentration.
AUC0-t of indapamide
Time frame: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose
The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on indapamide plasma concentration.
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 19 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets and Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets in people with Bioequivalence and Healthy Subjects, run by Darnitsa Pharmaceutical Company at 1 site in Jordan.
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 1 inclusion and 0 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 19 Jul 2022. 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 Jordan. 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?
Maximum plasma concentration (Cmax) of perindopril (time frame: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose). The study lists 4 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 19 Jul 2022.