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 Fasting Conditions.
Phase 1
19 Years
63 Years
19 Years
63 Years
Not Enrolling
Male
Prostate Cancer, Hirsutism
Male
Prostate Cancer, Hirsutism
Trial Information
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 Fasting Conditions.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Bioequivalence based on AUC and Cmax
Outcome Time Frame:
11 days
Safety Issue:
Yes
Principal Investigator
Richard Larouche, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Anapharm
Authority:
United States: Institutional Review Board
Study ID:
60110
NCT ID:
NCT00959335
Start Date:
August 2006
Completion Date:
August 2006
Related Keywords:
- Prostate Cancer
- Hirsutism
- treatment
- Hirsutism
- Hypertrichosis
- Prostatic Neoplasms
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