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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
Conditions
Interventions
PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets
TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets
Locations
1
Jordan
International Pharmaceutical Research Center
Amman, Jordan
Start Date
May 30, 2021
Primary Completion Date
June 28, 2021
Completion Date
June 28, 2021
Last Updated
July 22, 2022
NCT06342713
NCT06014515
NCT07219940
NCT07059858
NCT07144176
NCT07114146
Lead Sponsor
Darnitsa Pharmaceutical Company
Collaborators
Data Source & Attribution
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