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Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed Conditions

Primary Purpose

Prostate Cancer, Hirsutism

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Treatment

Eligibility Criteria

18 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

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

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)

    Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)

    Outcomes

    Primary Outcome Measures

    Bioequivalence based on AUC and Cmax

    Secondary Outcome Measures

    Full Information

    First Posted
    August 13, 2009
    Last Updated
    March 27, 2017
    Sponsor
    Sandoz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00960310
    Brief Title
    Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed 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 Fed Conditions.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 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 fed 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
    1
    Arm Type
    Experimental
    Arm Description
    Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    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)
    Intervention Type
    Drug
    Intervention Name(s)
    Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, 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
    18 Years
    Maximum Age & Unit of Time
    64 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 Fed Conditions

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