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

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

May 19, 2021

Primary Completion Date

June 9, 2021

Study Completion Date

June 9, 2021

Conditions
BioequivalenceHealthy Subjects
Interventions
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)

Trial Locations (1)

11196

International Pharmaceutical Research Center, Amman

All Listed Sponsors
collaborator

International Pharmaceutical Research Center

OTHER

lead

Darnitsa Pharmaceutical Company

INDUSTRY

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 | Biotech Hunter | Biotech Hunter