At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Bicalutamidedrug
Likely dose
Bicalutamide 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet Following a 50 mg Dose in Healthy Subjects Under Fed Conditions
In Brief
A Phase 1 clinical trial evaluating Bicalutamide for Healthy. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
CollaboratorsWatson Pharmaceuticals
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
Primary CompletionJul 2005
First PostedJan 2010
TodayJul 2026
First PostedJan 8, 2010
Enrollment StartMay 1, 2005
Primary CompletionJul 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.5 years ago
Interventions
Bicalutamidedrug
50 mg Oral Tablet