Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions
Sponsor
Sandoz (Industry)
Overall Status
Completed
CT.gov ID
NCT00959335
Collaborator
(none)
36
2
Study Details
Study Description
Brief Summary
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 fasting conditions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Fasting Conditions.
Study Start Date
:
Aug 1, 2006
Actual Primary Completion Date
:
Aug 1, 2006
Actual Study Completion Date
:
Aug 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 2 Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA) |
Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
|
| Experimental: 1 Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA) |
Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
|
Outcome Measures
Primary Outcome Measures
- Bioequivalence based on AUC and Cmax [11 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 63 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sandoz
Investigators
- Principal Investigator: Richard Larouche, M.D., Anapharm
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00959335
Other Study ID Numbers:
- 60110
First Posted:
Aug 14, 2009
Last Update Posted:
Mar 28, 2017
Last Verified:
Mar 1, 2017