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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02077803
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin, 100 mg — DRUG
    Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth).
  • Metformin XR, 500 mg — DRUG
    Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).
  • CANA/MET XR FDC, Formulation 1, 50 mg/1000 mg — DRUG
    Each tablet contains 50 mg of canagliflozin and 1000 mg of metformin HCl granulate, formulation 1, to be taken orally.
  • CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg — DRUG
    Each tablet contains 50 mg of canagliflozin and 1000 mg of metformin HCl granulate, formulation 2, to be taken orally.

Study Details

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.

Key Dates

Start date
Mar 31, 2014
Status verified
Sep 2014
Primary completion
Jul 31, 2014
Completion
Jul 31, 2014

Study Design

Enrollment
47 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A
    Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 100 mg, and 4 tablets of metformin extended release (MET XR), 500 mg, administered together under fed conditions.
  • Experimental: Treatment B
    Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 1, under fed conditions.
  • Experimental: Treatment C
    Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 2, under fed conditions.

Primary Outcome Measure

Plasma concentration of canagliflozin following the single dose of drug administration [ Time Frame: Day 1 to Day 2 (predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours postdose); Day 3 (48 hour); and Day 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-TempeArizona--

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