A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02073227
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

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/1,000 mg — DRUG
    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.
  • CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mg — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 28, 2014
Status verified
Sep 2014
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

Enrollment
52 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 4 tablets of metformin extended release (MET XR), 500 mg each, 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 administration of a single dose of study drug [ Time Frame: Predose, (before tablet intake) up to 72 hours after dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
-TempeArizona--

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