Clinical trial NCT05470764: Bioequivalence Study of 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide / 10 mg Amlodipine Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide / 10 mg Amlodipine Film-Coated Tablets in Healthy Volunteers
Official title: Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® TRIO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide/ 10 mg Amlodipine Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") And Reference Product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg Perindopril Arginine / 2.5 mg Indapamide / 10 mg Amlodipine Film-Coated Tablets (Manufactured By Servier (Ireland) Industries Ltd) In Healthy, Adult Subjects Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Healthy Subjects
Keywords: bioequivalence
perindopril
indapamide
amlodipine
healthy subjects
pharmacokinetics
Lead sponsor: Darnitsa Pharmaceutical Company
Sponsor class: INDUSTRY
Collaborators: name: International Pharmaceutical Research Center
First posted: 2022-07-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two-period, two-sequence, cross-over single dose study
Primary purpose: OTHER

Brief summary: The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" \[Ukraine\]) and a Reference medication (marketed medicinal product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets \[manufactured by Servier (Ireland) Industries Ltd\]) in healthy adult volunteers under fasting conditions.


Eligibility 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 the reference range after being evaluated by the physician as clinically not significant). Haematology tests within 5% of reference limits.

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of perindopril
timeFrame: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose
measure: Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of perindopril
timeFrame: Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose
measure: Cmax of indapamide
timeFrame: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose
measure: AUC0-t of indapamide
timeFrame: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose
measure: Cmax of amlodipine
timeFrame: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose
measure: Area under the concentration-time curve from time zero to 72 hours (AUC0-72) of amlodipine
timeFrame: Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: International Pharmaceutical Research Center
Study officials:
References: