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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

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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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Jan 2020

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At a glance

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

    • Most Recent Events

    • 13 Mar 2018 Primary endpoint (Bioequivalence Consideration: 90% Confidence Intervals for the Test:Reference Geometric Least Squares Mean Ratios) has been met as per the results published in the Clinical Therapeutics.
    • 13 Mar 2018 Results assessing bioequivalence published in the Clinical Therapeutics
    • 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.
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