An Open-Label, Randomized, Two-Period Crossover Definitive Bioequivalence Study With the FMI Sitagliptin/Metformin FDC Tablet and Co-Administration of the Sitagliptin and Metformin Individual Tablets After Consumption of a High-Fat Meal in Healthy Adult Subjects

Trial Profile

An Open-Label, Randomized, Two-Period Crossover Definitive Bioequivalence Study With the FMI Sitagliptin/Metformin FDC Tablet and Co-Administration of the Sitagliptin and Metformin Individual Tablets After Consumption of a High-Fat Meal in Healthy Adult Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 20 Aug 2015

At a glance

  • Drugs Metformin/sitagliptin (Primary) ; Metformin; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors Merck & Co
  • Most Recent Events

    • 22 Jul 2015 According to ClinicalTrials.gov record treatment pattern and serum sample collection time points (for calculation of AUC) had been changed.
    • 02 Feb 2010 Actual number of patients changed from 60 to 61 as reported by ClinicalTrials.gov.
    • 08 Jul 2009 New trial record.
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