NCT00972855

Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fed Conditions

Randomized, 1-Way, Parallel, Bioequivalence Study of Bicalutamide 50 mg Tablets and Casodex® Administered as 1 x 50 mg Tablet in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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 fed conditions.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Bicalutamide	50 mg Tablet
DRUG	Casodex®	50 mg Tablet

Timeline

• Start date: 2003-09-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2009-09-09
• Last updated: 2009-09-09

Locations

1 site across 1 country: Canada