A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01281579
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin.

Key Dates

Start date
Jan 31, 2011
Status verified
Nov 2012
Primary completion
Apr 30, 2011
Completion
Apr 30, 2011

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    Canagliflozin 50 mg Tablets oral 50-mg once daily on Day 1 and on Days 4 through 9.
  • Experimental: 002
    Canagliflozin 100 mg Tablets oral 100-mg once daily on Day 1 and on Days 4 through 9.
  • Experimental: 003
    Canagliflozin 300 mg Tablets oral 300-mg once daily on Day 1 and on Days 4 through 9.

Primary Outcome Measure

Plasma concentrations of canagliflozin [ Time Frame: At protocol-specified times up to Day 14 ]

Related Studies