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A Single-dose, Open-label, Randomized, 3 Period, 3 Treatment Crossover Study to Evaluate the Pharmacokinetics of Saxagliptin 5 mg and Dapagliflozin 10 mg When Coadministered to Fasted Healthy Subjects

Trial Profile

A Single-dose, Open-label, Randomized, 3 Period, 3 Treatment Crossover Study to Evaluate the Pharmacokinetics of Saxagliptin 5 mg and Dapagliflozin 10 mg When Coadministered to Fasted Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Aug 2016

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At a glance

  • Drugs Dapagliflozin (Primary) ; Saxagliptin (Primary)
  • Indications Type 1 diabetes mellitus; Type 2 diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors AstraZeneca
  • Most Recent Events

    • 09 Jun 2015 Primary endpoint has been met. (Maximum Observed Concentration (Cmax) of a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population), according to an abstract presented at the 75th Annual Scientific Sessions of the American Diabetes Association.
    • 09 Jun 2015 Primary endpoint has been met. (AUC(INF) of Saxagliptin From a Single Dose of 5 mg Saxagliptin Versus AUC(INF) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population), according to an abstract presented at the 75th Annual Scientific Sessions of the American Diabetes Association.
    • 09 Jun 2015 Primary endpoint has been met. (Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity [AUC(INF)] of Dapagliflozin From a Single Dose of Dapagliflozin Versus AUC (INF) of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population), according to an abstract presented at the 75th Annual Scientific Sessions of the American Diabetes Association.
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