Clinical Trial: Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed Conditions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Open-Label, 1-Way Parallel, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex (Reference) Following a 50 mg Dose in Healthy Subjects Under Fed Conditions.

Brief Summary: The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.

Detailed Summary:
Sponsor: Sandoz

Current Primary Outcome: Bioequivalence based on AUC and Cmax [ Time Frame: 11 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sandoz

Dates:
Date Received: August 13, 2009
Date Started: June 2006
Date Completion:
Last Updated: March 27, 2017
Last Verified: August 2009