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

Phase 1

Completed

• Conditions: Bioequivalence; Healthy Subjects
• Interventions: Drug: PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets; Drug: TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets

• Registration Number: NCT05470764
• Lead Sponsor: Darnitsa Pharmaceutical Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-30
• Primary Completion: 2021-06-28
• Study Completion: 2021-06-28
• Status Verified: 2022-07
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-22
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PERINDOPRES® TRIO (Test)	PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets	A single oral dose of the test product PERINDOPRES® TRIO 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets.
TRIPLIXAM® 10 mg /2.5 mg/10 mg	TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets	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.

Primary Outcome Measures

Name	Time	Method
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.
Cmax of indapamide	Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose	The Cmax value is based on indapamide plasma concentration.
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.
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.

Trial Locations

Locations (1)

International Pharmaceutical Research Center; 🇯🇴 Amman, Jordan