clinical trial · NCT00839930
Cilostazol 50 mg Tablets Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 30
HealthyCilostazol 50 mg TabletsPletal®
brief 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.
started
Feb 1, 2004
primary completion
Feb 1, 2004
completion
Feb 1, 2004
last updated
Aug 20, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Relative Bioavailability Study of 50 mg Cilostazol Tablets Under Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol