NCT05125549

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Joint Stock Company "Farmak" · Industry
• Sex: —
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine)	One film-coated tablet was administrated orally with 240 ml of water after an overnight fast
DRUG	Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)	One film-coated tablet was administrated orally with 240 ml of water after an overnight fast

Timeline

• Start date: 2018-07-12
• Primary completion: 2018-08-27
• Completion: 2018-08-27
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: Ukraine