Prostate Cancer Clinical Trial
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.
Verified date | August 2009 |
Source | Sandoz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: - Positive test results for HIV or hepatitis B or C. - Treatment for drug or alcohol dependence. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sandoz |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bioequivalence based on AUC and Cmax | 11 days |
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