Bioequivalence, Healthy Subjects
Conditions
Keywords
bioequivalence, perindopril, indapamide, healthy subjects, pharmacokinetics
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.
Interventions
DRUGPERINDOPRES® 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)
DRUGNoliterax® 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)
Sponsors
International Pharmaceutical Research Center
Darnitsa Pharmaceutical Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Two-period, two-sequence, cross-over single dose study
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) of perindopril | Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose | The Cmax values are based on perindopril plasma concentration. |
| Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of perindopril | Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose | 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. |
| Cmax of indapamide | Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose | The Cmax values are based on indapamide plasma concentration. |
| AUC0-t of indapamide | Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose | 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. |
Countries
Jordan
Outcome results
None listed