A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination (FDC) Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants (Humacao, Puerto Rico and Mount Vernon, US) in Healthy Subjects Under Fasting and Fed Conditions

Trial Profile

A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination (FDC) Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants (Humacao, Puerto Rico and Mount Vernon, US) in Healthy Subjects Under Fasting and Fed Conditions

Suspended
Phase of Trial: Phase I

Latest Information Update: 30 Nov 2017

At a glance

  • Drugs Dapagliflozin/metformin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors AstraZeneca
  • Most Recent Events

    • 27 Nov 2017 Status changed from recruiting to suspended.
    • 25 Oct 2017 Planned End Date changed from 16 Nov 2017 to 30 Jan 2018.
    • 25 Oct 2017 Planned primary completion date changed from 16 Nov 2017 to 30 Jan 2018.
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