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A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.

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A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Jun 2023

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At a glance

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

    • Most Recent Events

    • 27 Jun 2023 According to an AstraZeneca media release, based on results form this bioequivalence trial and the global diabetes program for Xigduo XR, the china NMPA has approved Xigduo XR for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycaemic control.
    • 05 Jul 2021 Status changed from recruiting to completed.
    • 24 May 2021 Planned End Date changed from 11 Aug 2021 to 10 Aug 2021.

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