Bioequivalence of Bicalutamide new formulation in Japan
Study identifier:D6874L00012
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
Bioequivalence study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex tablet (80mg)
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ICI176,334-1, Casodex 80 mg tablet
Sex
Male
Actual Enrollment
102
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Jul 2010
Primary Completion Date: 01 Nov 2010
Study Completion Date: 01 Nov 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2012 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Active 1 34 subjects will receive ICI176,334-1without water | Drug: ICI176,334-1 Subject will receive single dose of ICI176,334-1 |
| Experimental: Active 2 34 subjects will receive ICI176,334-1 with water | Drug: ICI176,334-1 Subject will receive single dose of ICI176,334-1 |
| Experimental: Active 3 34 subjects will receive Casodex 80 mg tablet | Drug: Casodex 80 mg tablet Subject will receive single dose of Casodex 80 mg tablet |
