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An Open-label, Randomized Two-Part, Two-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of Final Market Image (FMI) Sitagliptin /Metformin 50/500 mg and 50/1000 mg Fixed Dose Combination (FDC) and Concomitant Administration of 50 mg Doses of Sitagliptin and 500 or 1000 mg Doses of Metformin as Individual Tablets

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Trial Profile

An Open-label, Randomized Two-Part, Two-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of Final Market Image (FMI) Sitagliptin /Metformin 50/500 mg and 50/1000 mg Fixed Dose Combination (FDC) and Concomitant Administration of 50 mg Doses of Sitagliptin and 500 or 1000 mg Doses of Metformin as Individual Tablets

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 May 2022

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At a glance

  • Drugs Metformin/sitagliptin (Primary) ; Metformin; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors Merck & Co; Merck Sharp & Dohme Corp.

Most Recent Events

  • 29 Aug 2009 New trial record

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