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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-30

Study Completion Date

2021-06-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Bioequivalence Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PERINDOPRES® TRIO (Test)

A single oral dose of the test product PERINDOPRES® TRIO 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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).

TRIPLIXAM® 10 mg /2.5 mg/10 mg

A single oral dose of the reference product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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).

Interventions

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PERINDOPRES® 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).

Intervention Type DRUG

TRIPLIXAM® 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).

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes