A Bioequivalence Study of 2.5-mg Saxagliptin/5-mg Dapagliflozin and 5-mg Saxagliptin/10-mg Dapagliflozin Fixed Dose Combination Tablets Relative to Coadministration of Their Respective Individual Components in Healthy Subjects and a Characterization of the Effect of Food on the Fixed Dose Combination Tablets

Trial Profile

A Bioequivalence Study of 2.5-mg Saxagliptin/5-mg Dapagliflozin and 5-mg Saxagliptin/10-mg Dapagliflozin Fixed Dose Combination Tablets Relative to Coadministration of Their Respective Individual Components in Healthy Subjects and a Characterization of the Effect of Food on the Fixed Dose Combination Tablets

Completed
Phase of Trial: Phase I

Latest Information Update: 19 Jun 2015

At a glance

  • Drugs Dapagliflozin/saxagliptin (Primary) ; Dapagliflozin; Saxagliptin
  • Indications Diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 09 Jun 2015 Results presented at the 75th Annual Scientific Sessions of the American Diabetes Association.
    • 09 Jun 2015 Primary endpoint has been met. (Area under the drug concentration-time curve)
    • 09 Jun 2015 Primary endpoint has been met. (Peak drug concentration)
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