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

NCT05470764 | Completed Phase 1

• 1 other identifier: PER02-E
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioequivalence; Healthy Subjects

Keywords

bioequivalence; perindopril; indapamide; amlodipine; healthy subjects; pharmacokinetics

Outcome Measures

Primary Outcomes (6)

• Maximum plasma concentration (Cmax) of perindopril

  The Cmax value is based on perindopril plasma concentration.

  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.

  Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose

• Cmax of indapamide

  The Cmax value is based on indapamide plasma concentration.

  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.

  Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose

• Cmax of amlodipine

  The Cmax value is based on amlodipine plasma concentration.

  Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose

• Area under the concentration-time curve from time zero to 72 hours (AUC0-72) of amlodipine

  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.

  Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose

Study Arms (2)

PERINDOPRES® TRIO (Test)

EXPERIMENTAL

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

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

TRIPLIXAM® 10 mg /2.5 mg/10 mg

ACTIVE COMPARATOR

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.

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

Interventions

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

PERINDOPRES® TRIO (Test)

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

TRIPLIXAM® 10 mg /2.5 mg/10 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Darnitsa Pharmaceutical Company: lead
• International Pharmaceutical Research Center: collaborator

Study Sites (1)

International Pharmaceutical Research Center

Amman, 11196, Jordan

Location

MeSH Terms

Interventions

perindopril tert-butylamine; Indapamide; Amlodipine

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-period, two-sequence, cross-over single dose study

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: May 30, 2021
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

JO (1)