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
NCT02071368
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin, 300 mg — DRUG
    Each tablet contains canagliflozin (CANA) of 300 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, 150 mg/500 — DRUG
    Each tablet contains 150 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 1, to be taken orally.
  • CANA/MET XR FDC, Formulation 2, 150 mg/500 mg — DRUG
    Each tablet contains 150 mg of canagliflozin and 500 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 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.

Key Dates

Start date
Feb 28, 2014
Status verified
Jun 2014
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
3 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), 300 mg, and 2 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 (2 x \[150 mg/500 mg\]) formulation 1, under fed conditions.
  • Experimental: Treatment C
    Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC (2 x \[150 mg/500 mg\]), 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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