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 150 mg/1,000 mg) with respect to the individual components of
      canagliflozin (1 x 300 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 are 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 containing the 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 (150 mg CANA/1,000 mg MET XR) and will be compared
      with equal doses of the individual drugs: canagliflozin (1 x 300 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 administered concurrently; 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 the 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, an Open-Label Treatment Phase consisting of 3 single-dose Treatment
      Periods of 5 days each separated by a washout period of 10 to 14 days and a Follow-up Phase
      occurring 7 to 10 days after the last study-related procedure 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/1,000 mg; CANA/MET XR FDC, Formulation 2, 150 mg/1,000 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 1,000 mg of metformin HCl granulate formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally.; Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally.
Other intervention name(s): INVOKANA™; 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