drugset
drugset / Trial / NCT00839930

Cilostazol 50 mg Tablets Under Fasting Conditions

NCT00839930 ↗

Phase 1 Completed 30 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2004-02
Primary completion
2004-02
Completion
2004-02

Outcome

Met primary endpoint

registry analysis (unspecified test); Cilostazol vs Pletal®; Geometric Test/Ref Ratio x 100 93.39 (90% CI 87.33 to 99.86) NCT00839930 ↗

registry analysis (unspecified test); Cilostazol vs Pletal®; Geometric Test/Ref Ratio x 100 96.14 (90% CI 91.04 to 101.52) NCT00839930 ↗

registry analysis (unspecified test); Cilostazol vs Pletal®; Geometric Test/Ref Ratio x 100 96.64 (90% CI 92.13 to 101.37) NCT00839930 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cilostazol Small molecule 50 mg Oral

Indications

No indication recorded.