Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under fasting conditions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Randomized, 1-Way Parallel, Bioequivalence Study of Bicalutamide 50 mg Tablets and Casodex® Administered as 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions|
- Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
- AUC0-72: Area under the concentration-time curve from time zero to 72 hours post-dose. [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
|Study Completion Date:||September 2003|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
Experimental: Bicalutamide (test)
Bicalutamide Tablet, 50 mg
50 mg Tablet
Active Comparator: Casodex® (reference)
Casodex® Tablet, 50 mg
50 mg Tabelt
This will be a single center, bioequivalence, open-label, randomized, 1-way parallel study.
According to the BA/BE guidances, a parallel study is acceptable for drugs with a long half-life.