A Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01340677
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin, 50 mg — DRUG
    Type=1, unit=mg, number=50, form=tablet, route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.
  • Canagliflozin, 300 mg — DRUG
    Type=1, unit=mg, number=300, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.
  • Canagliflozin, 100 mg — DRUG
    Type=1, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.

Study Details

The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of canagliflozin in healthy volunteers.

Key Dates

Start date
May 31, 2011
Status verified
Aug 2012
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

Enrollment
24 participants (actual)
Intervention model
CROSSOVER

Arms

  • Experimental: 001
    Canagliflozin 100 mg Type=1 unit=mg number=100 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 300 mg Type=1 unit=mg number=300 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 50 mg Type=1 unit=mg number=50 form=tablet route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.

Primary Outcome Measure

Plasma concentrations of canagliflozin [ Time Frame: For up to 12 days (4 days during treatment periods 1, 2, and 3) ]

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