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

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-19

Study Completion Date

2021-06-09

Brief Summary

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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.

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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® DUO (Test)

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

Group Type EXPERIMENTAL

PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide 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) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure)

Noliterax® 10 mg/2.5 mg (Reference)

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.

Group Type ACTIVE_COMPARATOR

Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide 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) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure)

Interventions

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PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets

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)

Intervention Type DRUG

Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide 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) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure)

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 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes