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Fenofibrate Bioequivalence Study


filter terms:
  • diabetes
  • dyslipidemia
  • fenofibrate
  • high blood pressure
  • impaired glucose tolerance
    • Sizes of these terms reflect their relevance to your search.

    • Purpose

      This study will determine definitive bioequivalence of the US and UK formulations of fenofibrate following administration of single doses in healthy adult subjects.


      status: completed
      conditions: Dyslipidemia
      interventions: fenofibrate (US formulation) ; fenofibrate (UK formulation)
      phase: Phase 1
      study type: Interventional
      study design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study
      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

    • Further study details (as provided by Merck)

      primary outcome measures:

      • Area Under the Curve (AUC(0 to infinity)) and Peak Serum Concentration (Cmax) for the US and UK formulations [ Time Frame: Days 1 through 8 ]

      enrollment: 14

      study start date: February 2003

      study completion date: April 2004


      Arms Assigned Interventions

      1: Active Comparator

      Fenofibrate US Formulation

      Drug: fenofibrate (US formulation)

      Single dose of 160 mg fenofibrate US formulation (Tricor®) in one of two treatment periods.

      2: Active Comparator

      Fenofibrate UK Formulation

      Drug: fenofibrate (UK formulation)

      Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.

    • Eligibility

      ages eligible for study: 18 Years to 45 Years
      genders eligible for study: Both

      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

    • Contacts and locations

      Please refer to this study by its ClinicalTrials.gov identifier: NCT00928694

    • Sponsors and collaborators

      Merck

      investigators: Medical Monitor, Study Director, Merck

    • More information

      first received: June 25, 2009
      last updated: June 25, 2009
      ClinicalTrials.gov Identifier: NCT00928694
      health authority: United States: Food and Drug Administration

    Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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