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 — DRUGOne 1.25 mg tablet taken orally (by mouth) on Day 1 and Day 9.
- Canagliflozin (JNJ-28431754) — DRUGOne 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) + glyburideEach 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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