Bioequivalence Study of 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide / 10 mg Amlodipine Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide / 10 mg Amlodipine Film-Coated Tablets in Healthy Volunteers

Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® TRIO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide/ 10 mg Amlodipine Tablets (PrJSC Pharmaceutical Firm Darnitsa) And Reference Product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg Perindopril Arginine / 2.5 mg Indapamide / 10 mg Amlodipine Film-Coated Tablets (Manufactured By Servier (Ireland) Industries Ltd) In Healthy, Adult Subjects Under Fasting Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05470764

Enrollment

Registered

2022-07-22

Start date

2021-05-30

Completion date

2021-06-28

Last updated

2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence, Healthy Subjects

Keywords

bioequivalence, perindopril, indapamide, amlodipine, healthy subjects, pharmacokinetics

Brief summary

The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets manufactured by PrJSC Pharmaceutical firm Darnitsa \[Ukraine\]) and a Reference medication (marketed medicinal product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets \[manufactured by Servier (Ireland) Industries Ltd\]) in healthy adult volunteers under fasting conditions.

Interventions

DRUGPERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets

Oral, generic fixed-dose combination of perindopril tert-butylamine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure), indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) and amlodipine (calcium channel blocker used to treat high blood pressure and coronary artery disease).

DRUGTRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets

Oral, innovative fixed-dose combination of perindopril arginine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure), indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) and amlodipine (calcium channel blocker used to treat high blood pressure and coronary artery disease).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Intervention model description

Two-period, two-sequence, cross-over single dose study

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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 the reference range after being evaluated by the physician as clinically not significant). Haematology tests within 5% of reference limits.

Design outcomes

Primary

Measure	Time frame	Description
Maximum plasma concentration (Cmax) of perindopril	Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose	The Cmax value is based on perindopril plasma concentration.
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of perindopril	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	Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose	The Cmax value is based on indapamide plasma concentration.
AUC0-t of indapamide	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.
Cmax of amlodipine	Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose	The Cmax value is based on amlodipine plasma concentration.
Area under the concentration-time curve from time zero to 72 hours (AUC0-72) of amlodipine	Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose	The AUC0-72 is the area under the plasma concentration versus time curve from time zero (predose) to 72 hours and is based on amlodipine plasma concentration.

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026