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 (150 mg/500 mg) With Respect to the Metformin XR Tablet (Locally Sourced From Canada [GLUMETZA, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 100 mg + 1 x 50 mg) in Healthy Fed and Fasted Subjects

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 (150 mg/500 mg) With Respect to the Metformin XR Tablet (Locally Sourced From Canada [GLUMETZA, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 100 mg + 1 x 50 mg) in Healthy Fed and Fasted Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 08 Dec 2016

At a glance

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

    • 05 Dec 2016 Status changed from recruiting to completed.
    • 06 Sep 2016 Status changed from not yet recruiting to recruiting.
    • 15 Aug 2016 Planned End Date changed from 1 Nov 2016 to 1 Oct 2016.
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