A Randomised, 3-Period, 3-Treatment, Single-dose, Open-label, Single-center, Crossover Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin / 10 mg Dapagliflozin / 1000 mg Metformin XR Relative to Individual Components (Onglyza and XIGDUO XR) Co-administered to Healthy Subjects

Trial Profile

A Randomised, 3-Period, 3-Treatment, Single-dose, Open-label, Single-center, Crossover Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin / 10 mg Dapagliflozin / 1000 mg Metformin XR Relative to Individual Components (Onglyza and XIGDUO XR) Co-administered to Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 17 Aug 2017

At a glance

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

    • 11 Aug 2017 Status changed from active, no longer recruiting to completed.
    • 02 Aug 2017 Status changed from recruiting to active, no longer recruiting.
    • 02 Jun 2017 New trial record
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