NCT05464745

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

Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® DUO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") and Reference 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, Adult Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Darnitsa Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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)
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)

Timeline

• Start date: 2021-05-19
• Primary completion: 2021-06-09
• Completion: 2021-06-09
• First posted: 2022-07-19
• Last updated: 2022-07-19

Locations

1 site across 1 country: Jordan