An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin Modified Release Film-coated Tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) Versus the Combined Use of Forxiga (Dapagliflozin), Film-coated Tablets, 10 mg (Bristol Myers Squibb Company, USA) and Two Glucophage Long (Metformin), ER Tablets, 500 mg (Merck Santé S.A.S., France), Co-administered to Healthy Volunteers Under Standard Fed Conditions

Trial Profile

An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin Modified Release Film-coated Tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) Versus the Combined Use of Forxiga (Dapagliflozin), Film-coated Tablets, 10 mg (Bristol Myers Squibb Company, USA) and Two Glucophage Long (Metformin), ER Tablets, 500 mg (Merck Santé S.A.S., France), Co-administered to Healthy Volunteers Under Standard Fed Conditions

Completed
Phase of Trial: Phase I

Latest Information Update: 13 Jun 2017

At a glance

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

    • 13 Jun 2017 Primary endpoint (Area under the concentration - time curve (AUC0-t)) has been met for bioequivalence, according to results presented at the 77th Annual Scientific Sessions of the American Diabetes Association.
    • 13 Jun 2017 Primary endpoint (Maximum concentration (Cmax)) has been met for bioequivalence, according to results presented at the 77th Annual Scientific Sessions of the American Diabetes Association.
    • 13 Jun 2017 Results presented at the 77th Annual Scientific Sessions of the American Diabetes Association.
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