Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 x 500 mg Glucophage XR Coadministered to Healthy Subjects in the Fed State and Steady State Pharmacokinetic Assessment of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR

Trial Profile

Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 x 500 mg Glucophage XR Coadministered to Healthy Subjects in the Fed State and Steady State Pharmacokinetic Assessment of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR

Completed
Phase of Trial: Phase I

Latest Information Update: 19 May 2015

At a glance

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

    • 08 Nov 2010 Extended-release saxagliptin/metformin [KOMBIGLYZE XR] has received FDA approval for the treatment of type 2 diabetes mellitus, according to a Bristol-Myers Squibb media release.
    • 09 Sep 2010 New trial record
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