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

Summary: 
      The purpose of this study is to assess the bioequivalence (similarity of the drug amount in
      blood among the formulations) 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/1000
      mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR
      tablet (4 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 Fixed Dose Combination (FDC) tablets of canagliflozin (CANA) and
      metformin extended release (MET XR) 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/1,000 mg MET XR) and will be compared with
      equal doses of the individual drugs: canagliflozin (1 x 100 mg tablet) and metformin XR (4 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/1000 mg; CANA/MET XR FDC, Formulation 2, 50 mg/1000 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 1000 mg of metformin HCl granulate, formulation 1, to be taken orally.; Each tablet contains 50 mg of canagliflozin and 1000 mg of metformin HCl granulate, formulation 2, to be taken orally.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin; Metformin; Type 2 diabetes mellitus; Bioequivalence; GLUMETZA®