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A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State.

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Trial Profile

A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 May 2017

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At a glance

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

    • Most Recent Events

    • 01 Mar 2016 Primary endpoint has been met. (Bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.), as per results published in the Clinical Pharmacology in Drug Development.
    • 01 Mar 2016 Results published in the Clinical Pharmacology in Drug Development
    • 18 Apr 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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