A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01508195
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin tablets — 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 1.
  • Metformin IR tablets — DRUG
    Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.
  • Canagliflozin/metformin IR FDC tablets — DRUG
    Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.
  • Canagliflozin/metformin IR FDC tablets — DRUG
    Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.
  • Canagliflozin tablets — 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 2.
  • Metformin IR tablets — DRUG
    Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.

Study Details

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

Key Dates

Start date
Jan 31, 2012
Status verified
Jan 2013
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

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

Arms

  • Experimental: Treatment Sequence AB
    Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods.
  • Experimental: Treatment Sequence BA
    Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods.

Primary Outcome Measure

Canagliflozin plasma concentrations [ Time Frame: Up to 72 hours in Treatment Period 1 and Treatment Period 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-LincolnNebraska--

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