A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of the fixed dose combination (two
      components combined in one tablet) of canagliflozin and metformin extended release (XR)
      tablet (dose of 2 X 50 mg/500 mg) with respect to the individual components of canagliflozin
      (1 x 100 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), open-label (physicians and
      participants know the identity of the assigned treatment), single-center, single-dose,
      3-treatment, 3-way crossover (the same medications provided to all participants but in
      different sequence) study of canagliflozin (CANA) and metformin extended release (MET XR)
      combined in one tablet, in comparison with tablets of individual components. Two Fixed Dose
      Combinations (FDCs) will be evaluated during the study (two types of tablets). The tablets
      will be of the same strength (50 mg CANA/500 mg MET XR) and will be compared with the equal
      doses of the individual drugs: canagliflozin (1 x 100 mg tablet) and metformin XR (2 x 500 mg
      tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference"
      treatment of individual components. Treatment B: CANA/MET XR FDC, formulation 1; and
      Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will
      be randomly assigned to 1 of 3 treatments groups, and then each group will receive all three
      treatments in different sequences (3-way crossover). The study will consist of 3 phases: a
      Screening Phase of approximately 3 weeks (Days -22 to -2), an Open-Label Treatment Phase
      consisting of 3 single-dose Treatment Periods of 5 days each (Days -1 through 4) separated by
      a washout of 10 to 14 days between Day 1 of each Treatment Period, and a Follow-up Phase
      occurring 7 to 10 days after the last study-related procedure on Day 4 of Treatment Period 3.
      The total duration of the study will be about 70 days for each participant.
    

Intervention name(s): Canagliflozin, 100 mg; Metformin XR, 500 mg; CANA/MET XR FDC, Formulation 1, 50 mg/500 mg; CANA/MET XR FDC, Formulation 2, 50 mg/500 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth).; Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).; Each tablet contains 50 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally.; Each tablet contains 50 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally.
Other intervention name(s): GLUMETZA®
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Canagliflozin; Metformin; Type 2 diabetes mellitus