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A Randomized, Open-label, Two-way Crossover Study Assessing the Bioequivalence (BE) Between Single Dose of 750 mg Glucophage XR Tablets (PT Merck Tbk, Jakarta, Indonesia-Manufactured) and 750 mg Glucophage XR Tablets (Merck Santé, Semoy, France-Manufactured) Under Fasted State in Healthy Subjects

Trial Profile

A Randomized, Open-label, Two-way Crossover Study Assessing the Bioequivalence (BE) Between Single Dose of 750 mg Glucophage XR Tablets (PT Merck Tbk, Jakarta, Indonesia-Manufactured) and 750 mg Glucophage XR Tablets (Merck Santé, Semoy, France-Manufactured) Under Fasted State in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 07 Dec 2018

At a glance

  • Drugs Metformin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors Merck KGaA
  • Most Recent Events

    • 15 Oct 2018 Status changed from recruiting to completed.
    • 06 Sep 2018 Status changed from not yet recruiting to recruiting.
    • 25 Jul 2018 Planned End Date changed from 31 Aug 2018 to 27 Sep 2018.
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