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A Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage Extended Release (GXR) Tablets (Merck/China Nantong-Manufactured) and 500 mg GXR Tablets (Merck/Germany Darmstadt-Manufactured) Under Fed and Fasted State in Two Groups of Healthy Volunteers

Trial Profile

A Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage Extended Release (GXR) Tablets (Merck/China Nantong-Manufactured) and 500 mg GXR Tablets (Merck/Germany Darmstadt-Manufactured) Under Fed and Fasted State in Two Groups of Healthy Volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 26 Dec 2018

At a glance

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

    • 18 Dec 2018 Status changed from recruiting to completed.
    • 09 Nov 2018 Planned End Date changed from 28 Apr 2020 to 8 Nov 2018.
    • 09 Nov 2018 Planned primary completion date changed from 28 Apr 2020 to 8 Nov 2018.
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