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Fasted Bioequivalence Study of Clopidogrel Film-coated Tablets, 75 mg in 48 Healthy, Adult Male and Female Subjects.

Pharmacokinetics Clinical Trial

Official title:
Fasting, Comparative, Open-label, Randomized, Four-period, Two-sequence, Bioequivalence Study of Сlopidogrel Bisulfate Film-coated Tablets, 75 mg (JSC Farmak, Ukraine) vs Plavix® 75 mg Film-coated Tablets in Healthy Adult Subjects

Clinical Trial Summary

This study was designed to compare bioequivalence of the Test Product Clopidogrel bisulfate, film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) in healthy male and female volunteers under fasting conditions.

Clinical Trial Description

An open, comparative, randomized, four-period, two- sequence, two-way crossover clinical trial to evaluate the Bioequivalence of Single Doses of Test Product Clopidogrel bisulfate, film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) in healthy adult male and female volunteers under fasting conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05125549
Study type Interventional
Source Joint Stock Company "Farmak"
Contact
Status Completed
Phase Phase 1
Start date July 12, 2018
Completion date August 27, 2018
View Details
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