NCT05186129

Bioequivalence Study of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® 75 mg Tablet After Oral Administration to Healthy Adult Subjects Under Fasting Condition

To Determine the Bioequivalence of Clopid® (Clopidogrel) 75 mg Tablet Manufactured by Ferozsons Laboratories Ltd. Pakistan and Plavix® 75 mg Tablet Manufactured by Sanofi Winthrop Industrie France for Sanofi Pakistan After Oral Administration to Healthy Adult Male Subjects Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Center for Bioequivalence Studies and Clinical Research · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare the rate and extent of absorption of Clopid® (Clopidogrel) 75 mg Tablet and Plavix® (clopidogrel) 75 mg tablet under fasting condition.

Detailed description

Single dose, Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopid® of Ferozsons Laboratories Limited and Plavix® of Sanofi Winthrop Industrie France for Sanofi Pakistan Following a 75 mg Dose In Healthy Subjects Under Fasting Condition.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Clopid® 75 mg Tablet	Single dose of Clopid® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.
DRUG	Plavix® 75mg Tablet	Single dose of Plavix® 75 mg Tablet (Clopidogrel) was administered after a 10-hour overnight fast.

Timeline

• Start date: 2018-04-06
• Primary completion: 2018-04-15
• Completion: 2018-04-20
• First posted: 2022-01-11
• Last updated: 2022-03-02

Locations

1 site across 1 country: Pakistan