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 150
      mg/500mg) with respect to the individual components of canagliflozin (1 x 300 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 a Fixed Dose Combination (FDC) tablets of canagliflozin (CANA)
      and metformin extended release (MET XR) in comparison with tablets of individual components.
      Two FDC tablets will be studied with different formulations of MET XR component (CANA
      component will be identical). Both FDCs will be of the same strength: 2 tablets of 150mg
      CANA/500mg MET XR and will be compared with the equal doses of the individual drugs:
      canagliflozin (1 x 300mg tablet) and metformin XR (2 x 500mg 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, 300 mg; Metformin XR, 500 mg; CANA/MET XR FDC, Formulation 1, 150 mg/500; CANA/MET XR FDC, Formulation 2, 150 mg/500 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each tablet contains canagliflozin (CANA) of 300 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 150 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 1, to be taken orally.; Each tablet contains 150 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 2, 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; Canagliflozin; Metformin; JNJ-28431754; GLUMETZA®; Bioequivalence; Fixed Dose Combination