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Fenofibrate Bioequivalence Study (0767-031)

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
fenofibrate (U.S. formulation)
fenofibrate (UK formulation)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is in good health
  • Subject is willing to follow all study guidelines

Exclusion Criteria:

  • Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe
  • Female subject is receiving oral contraceptives or hormone replacement therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Fenofibrate U.S. Formulation

    Fenofibrate UK Formulation

    Outcomes

    Primary Outcome Measures

    Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid
    Maximum Plasma Concentration (Cmax) of Fenofibric Acid

    Secondary Outcome Measures

    Full Information

    First Posted
    June 25, 2009
    Last Updated
    August 18, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00928694
    Brief Title
    Fenofibrate Bioequivalence Study (0767-031)
    Official Title
    An Open-Label, Randomized, 2-Period, Crossover Study to Determine Definitive Bioequivalence After Administration of Single 160 mg Doses of the U.S. and UK Formulations of Fenofibrate in Healthy Adult Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2003 (undefined)
    Primary Completion Date
    April 2003 (Actual)
    Study Completion Date
    April 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Fenofibrate U.S. Formulation
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Fenofibrate UK Formulation
    Intervention Type
    Drug
    Intervention Name(s)
    fenofibrate (U.S. formulation)
    Other Intervention Name(s)
    Tricor®
    Intervention Description
    Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.
    Intervention Type
    Drug
    Intervention Name(s)
    fenofibrate (UK formulation)
    Other Intervention Name(s)
    Supralip®
    Intervention Description
    Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.
    Primary Outcome Measure Information:
    Title
    Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid
    Time Frame
    Predose and up to 168 hours postdose
    Title
    Maximum Plasma Concentration (Cmax) of Fenofibric Acid
    Time Frame
    Predose and up to 168 hours postdose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject is in good health Subject is willing to follow all study guidelines Exclusion Criteria: Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe Female subject is receiving oral contraceptives or hormone replacement therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Fenofibrate Bioequivalence Study (0767-031)

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