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A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) 1 x (50 mg/500 mg) With Respect to the Metformin XR Tablet (Locally Sourced From Canada [GLUMETZA, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 50 mg) in Healthy Fed and Fasted Subjects

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Trial Profile

A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) 1 x (50 mg/500 mg) With Respect to the Metformin XR Tablet (Locally Sourced From Canada [GLUMETZA, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 50 mg) in Healthy Fed and Fasted Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 Feb 2017

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At a glance

  • Drugs Canagliflozin/metformin (Primary) ; Canagliflozin; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacokinetics; Registrational
  • Sponsors Janssen Research & Development

    • Most Recent Events

    • 08 Feb 2017 Status changed from recruiting to completed.
    • 17 Aug 2016 Status changed from not yet recruiting to recruiting.
    • 17 Aug 2016 New trial record

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