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To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)
Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)
Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring Anti-Inflammatory

Eligibility Criteria

18 Years - 40 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

    Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)

    Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)

    Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)

    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
    NCT00913887
    Brief Title
    To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions
    Official Title
    A Relative Bioavailability Study of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1994 (undefined)
    Primary Completion Date
    May 1994 (Actual)
    Study Completion Date
    May 1994 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sandoz

    4. Oversight

    5. Study Description

    Brief Summary
    To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets under non-fasting conditions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation
    Keywords
    Anti-Inflammatory

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)
    Intervention Type
    Drug
    Intervention Name(s)
    Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)
    Primary Outcome Measure Information:
    Title
    Bioequivalence based on AUC and Cmax
    Time Frame
    32 days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 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
    Paul D. Larsen, M.D.
    Organizational Affiliation
    Red River Clinical
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions

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