NCT00648388

Fasting Study of Cilostazol Tablets 100 mg and Pletal® Tablets 100 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Cilostazol Tablets (100 mg; Mylan) and Pletal® Tablets(100 mg; Otsuka) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cilostazol Tablets 100 mg	100mg, single dose fasting
DRUG	Pletal® Tablets 100 mg	100 single dose fasting

Timeline

• Start date: 2004-03-01
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2008-04-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States