A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01286103
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen in healthy adult volunteers

Key Dates

Start date
Jan 31, 2011
Status verified
Mar 2012
Completion
May 31, 2011

Study Design

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

Arms

  • Experimental: 001
    Canagliflozin 300 mg once daily and 150 mg twice daily Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.
  • Experimental: 002
    Canagliflozin 100 mg once daily and 50 mg twice daily Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.

Primary Outcome Measure

Plasma concentrations of canagliflozin [ Time Frame: Up to Day 5 after the last treatment ]

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