NCT00839930

Cilostazol 50 mg Tablets Under Fasting Conditions

A Relative Bioavailability Study of 50 mg Cilostazol Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 50 mg Cilostazol Tablets manufactured by TEVA Pharmaceuticals Industries Ltd. and distributed by TEVA Pharmaceuticals USA with that of PLETAL Tablets manufactured by Otsuka Pharmaceuticals Co., Ltd. for Otsuka America Pharmaceutical, Inc. following a single oral dose (1 x 50 mg tablet) in healthy adult subjects administered under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cilostazol 50 mg Tablets	1 x 50 mg, single-dose fasting
DRUG	Pletal®	1 x 50 mg, single-dose tablet

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2009-02-10
• Last updated: 2024-08-20
• Results posted: 2009-07-21

Locations

2 sites across 1 country: United States