A Drug Interaction Study of Warfarin and Canagliflozin in Healthy Adult Volunteers

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01195324
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin/Warfarin — DRUG
    Treatment A: Tablets, oral, canagliflozin 300 mg, once daily for 12 days and canagliflozin 300 mg + warfarin 30 mg, single dose on Day 6 followed 14 days later by Treatment B: Tablets, oral, warfarin 30 mg, single dose on Day 1
  • Canagliflozin/Warfarin — DRUG
    Treatment B: Tablets, oral, warfarin 30 mg, single dose on Day 1 followed 14 days later by Treatment A: Tablets, oral, canagliflozin 300 mg, once daily for 12 days and canagliflozin 300 mg + warfarin 30 mg, single dose on Day 6

Study Details

The purpose of the study is to assess the effect of multiple oral doses of canagliflozin on a single oral dose of warfarin.

Key Dates

Start date
Sep 30, 2010
Status verified
May 2014
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Experimental: 001
    Canagliflozin/Warfarin Treatment A: Tablets oral canagliflozin 300 mg once daily for 12 days and canagliflozin 300 mg + warfarin 30 mg single dose on Day 6 followed 14 days later by Treatment B: Tablets oral warfarin 30 mg single dose on Day 1
  • Experimental: 002
    Canagliflozin/Warfarin Treatment B: Tablets oral warfarin 30 mg single dose on Day 1 followed 14 days later by Treatment A: Tablets oral canagliflozin 300 mg once daily for 12 days and canagliflozin 300 mg + warfarin 30 mg single dose on Day 6

Primary Outcome Measure

Plasma concentrations of canagliflozin [ Time Frame: At protocol-specified times during Treatment A on Days 1 through 12. ]

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