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Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Eplerenone 50 mg Tablets Sandoz Inc., USA
Inspra 50 mg Tablets GD Searle LLC, USA
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

    Eplerenone 50mg Tablets

    INSPRA 50mg Tablets

    Outcomes

    Primary Outcome Measures

    Bioequivalence according to US FDA guidelines

    Secondary Outcome Measures

    Full Information

    First Posted
    March 18, 2009
    Last Updated
    March 27, 2017
    Sponsor
    Sandoz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00865618
    Brief Title
    Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions
    Official Title
    Comparative Bioavailability Study of Eplerenone 50 mg Tablets (Sandoz Inc., USA) and Inspra 50 mg Tablets (GD Searle LLC, USA) in Healthy Male and/or Female Volunteers Under Fed Conditions.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 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 bioequivalence of Eplerenone 50 mg Tablets Under Fed Conditions.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Eplerenone 50mg Tablets
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    INSPRA 50mg Tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Eplerenone 50 mg Tablets Sandoz Inc., USA
    Intervention Type
    Drug
    Intervention Name(s)
    Inspra 50 mg Tablets GD Searle LLC, USA
    Primary Outcome Measure Information:
    Title
    Bioequivalence according to US FDA guidelines
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 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
    Deepen Patel, M.D., CCFP
    Organizational Affiliation
    Allied Research International Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions

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