A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01733108
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Glyburide — DRUG
    One 1.25 mg tablet taken orally (by mouth) on Day 1 and Day 9.
  • Canagliflozin (JNJ-28431754) — DRUG
    One 200 mg tablet taken orally (by mouth) on Days 4 through 9.

Study Details

The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of a single dose of glyburide.

Key Dates

Start date
Jul 31, 2008
Status verified
Dec 2012
Primary completion
Sep 30, 2008
Completion
Sep 30, 2008

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin (JNJ-28431754) + glyburide
    Each volunteer will receive a single dose of glyburide on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 4 through 8. On Day 9 volunteers will receive a single dose of glyburide in combination with a single dose of canagliflozin.

Primary Outcome Measure

Plasma concentrations of glyburide [ Time Frame: Up to Day 12 ]

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