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

NCT05464745 | Completed Phase 1

• 1 other identifier: PER03-E
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bioequivalence; Healthy Subjects

Keywords

bioequivalence; perindopril; indapamide; healthy subjects; pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Maximum plasma concentration (Cmax) of perindopril

  The Cmax values are 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 values are 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

Study Arms (2)

PERINDOPRES® DUO (Test)

EXPERIMENTAL

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

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

Noliterax® 10 mg/2.5 mg (Reference)

ACTIVE COMPARATOR

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.

Drug: Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets

Interventions

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

PERINDOPRES® DUO (Test)

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

Noliterax® 10 mg/2.5 mg (Reference)

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 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.

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

Intervention Hierarchy (Ancestors)

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

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 18, 2022
• First Posted: July 19, 2022
• Study Start: May 19, 2021
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)