A Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers
NCT01428284 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2012-02-17
Summary
The purpose of this study is to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. Safety and tolerability will also be assessed.
Conditions
- Healthy
Interventions
- DRUG
-
Canagliflozin/Probenecid
Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Probenicid: Type = 1, unit = mg, number = 500, form = tablet, route = oral use. One 300-mg canagliflozin tablet taken orally once daily on Days 1 to 14 (administration of canagliflozin alone) and on Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid).
Sponsors & Collaborators
-
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
lead INDUSTRY
Principal Investigators
-
Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 15 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2011-10-31
- Completion
- 2011-10-31
Countries
- United States
Study Locations
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