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

Darnitsa Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Bioequivalence

Healthy Subjects

Treatments

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

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

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05464745

PER03-E

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 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.