A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01463774
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Treatment A: Canagliflozin tablet — DRUG
    Type=exact number, unit=mg, number=100, form=tablet, route=oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period A.
  • Treatment A: Metformin IR tablets — DRUG
    Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.
  • Treatment B: Canagliflozin/metformin fixed dose combination tablets — DRUG
    Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.

Study Details

The purpose of this study is to evaluate the bioequivalence of a fixed dose combination tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

Key Dates

Start date
Sep 30, 2011
Status verified
Nov 2012
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011

Study Design

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

Arms

  • Experimental: Treatment Sequence AB
    The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days.
  • Experimental: Treatment Sequence BA
    The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days.

Primary Outcome Measure

Canagliflozin plasma concentrations [ Time Frame: Up to 72 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
-LincolnNebraska--

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