Back to resultsRelative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions
Primary Purpose
Prostate Cancer, Hirsutism
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring treatment
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2
1
Arm Description
Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00959335
Brief Title
Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions
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 Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Hirsutism
Keywords
treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
Arm Title
1
Arm Type
Experimental
Arm Description
Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
Intervention Type
Drug
Intervention Name(s)
Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
Intervention Type
Drug
Intervention Name(s)
Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
11 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Larouche, M.D.
Organizational Affiliation
Anapharm
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions
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