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To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions

Primary Purpose

Depression

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)
Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)
Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 45 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 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)

    Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)

    Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)

    Outcomes

    Primary Outcome Measures

    Bioequivalence based on AUC and Cmax

    Secondary Outcome Measures

    Full Information

    First Posted
    June 2, 2009
    Last Updated
    March 27, 2017
    Sponsor
    Sandoz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00913588
    Brief Title
    To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions
    Official Title
    Comparative, Randomized, Single-Dose, 3-way Crossover Bioavailability Study of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Health Adult Males Under Fed and Fasted Conditions Following Administration of a 40 mg Dose
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1996 (undefined)
    Primary Completion Date
    August 1996 (Actual)
    Study Completion Date
    August 1996 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sandoz

    4. Oversight

    5. Study Description

    Brief Summary
    To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fed and fasted conditions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)
    Intervention Type
    Drug
    Intervention Name(s)
    Fluoxetine HCl 20 mg Capsules Under Fasting Conditions (Geneva Pharmaceutical, Inc.)
    Intervention Type
    Drug
    Intervention Name(s)
    Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Geneva Pharmaceutical, Inc.)
    Intervention Type
    Drug
    Intervention Name(s)
    Prozac Fluoxetine HCl 20 mg Capsules Under Fed Conditions (Dista)
    Primary Outcome Measure Information:
    Title
    Bioequivalence based on AUC and Cmax
    Time Frame
    141 days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 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
    Roderick Malone, M.D.
    Organizational Affiliation
    Clinical Research Center (Cincinnati)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions

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