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A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Fed Subjects.

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Trial Profile

A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Fed Subjects.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 May 2013

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At a glance

  • Drugs Canagliflozin/metformin (Primary) ; Canagliflozin; Metformin
  • Indications Hyperglycaemia; Type 2 diabetes mellitus
  • Focus Pharmacokinetics

    • Most Recent Events

    • 21 Feb 2012 Actual end date (Nov 2011) added as reported by ClinicalTrials.gov.
    • 21 Feb 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 29 Nov 2011 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.

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