A Study to Evaluate the Effects of Rifampin on Single-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01395927
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Rifampin — DRUG
    Type=2, unit=mg, number=300, Form=capsule, route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.
  • Canagliflozin — DRUG
    Type=1, unit=mg, number=300, form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10

Study Details

The purpose of this study is to evaluate blood levels of canagliflozin in healthy volunteers before and after the administration of multiple-doses of rifampin.

Key Dates

Start date
Jul 31, 2011
Status verified
May 2013
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP

Arms

  • Experimental: 001
    Canagliflozin Type=1 unit=mg number=300 form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10,Rifampin Type=2 unit=mg number=300 Form=capsule route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.

Primary Outcome Measure

Plasma concentrations of canagliflozin [ Time Frame: Day 1 up to Day 13 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-Overland ParkKansas--

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