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Clinical trial

Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® DUO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") and Reference 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, Adult Subjects Under Fasting Conditions

NCT05464745 is registered in ClinicalTrials.gov with Darnitsa Pharmaceutical Company as lead sponsor.

NCT NCT05464745
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Registry record

As filed in ClinicalTrials.gov.

Title
Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® DUO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") and Reference 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, Adult Subjects Under Fasting Conditions
Lead sponsor
Darnitsa Pharmaceutical Company
Phase
Phase 1
Overall status
Completed
Start date
May 19, 2021
Completion date
June 9, 2021
Enrollment
42 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

bioequivalence, healthy subjects