NCT01044706

Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet in Healthy Subjects Under Fed Conditions

Randomized, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet Following a 50 mg Dose in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kremers Urban Development Company · Industry
• Sex: Male
• Age: 19 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablet (test) versus Casodex® (reference), administered as 1 x 50 mg tablet under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Bicalutamide	50 mg Oral Tablet

Timeline

• Start date: 2005-05-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2010-01-08
• Last updated: 2010-03-02
• Results posted: 2010-03-01

Locations

1 site across 1 country: Canada