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A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin XR Tablet (4 x 500 mg) in Healthy Fed Subjects

Trial Profile

A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin XR Tablet (4 x 500 mg) in Healthy Fed Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Aug 2014

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At a glance

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

    • 12 Aug 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 16 Jun 2014 Planned End Date changed from 1 May 2014 to 1 Jun 2014 as reported by ClinicalTrials.gov record.
    • 11 Apr 2014 According to the ClinicalTrials.gov record, status changed from not yet recruiting to recruiting.
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