A Study to Assess the Bioequivalence of Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Healthy Chinese Subjects.
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence between dapagliflozin/metformin XR FDC tablet and
      co-administration of dapagliflozin and metformin XR tablets.
    

Detailed description: 
      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.
    

Intervention name(s): Dapagliflozin/metformin XR FDC 5/500 mg; Dapagliflozin/metformin XR FDC 10/1000 mg; Dapagliflozin 5 mg + Metformin 500 mg XR; Dapagliflozin 10 mg + Metformin 1000 mg XR
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence.; In cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence.; In cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence.; In cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence.
Other intervention name(s): Xigduo XR; Xigduo XR; Forxiga + Glucophage XR; Forxiga + Glucophage XR
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: There will be two independent cohorts of subjects who will each receive two treatments in a randomized order, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability. In each cohort approximately 40 healthy subjects will be randomized to receive treatment with IP in order to complete at least 36 evaluable subjects.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dapagliflozin; Forxiga; Metformin XR; Glucophage XR; Xigduo XR; Bioequivalence; Cross-over