A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study ID
- NCT01748526
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Canagliflozin (JNJ-28431754) 200 mg — DRUGOne 200 mg tablet taken orally (by mouth) on Day 1.
- Canagliflozin (JNJ-28431754) 300 mg — DRUGOne 300 mg tablet taken orally (by mouth) on Day 1.
Study Details
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of canagliflozin (JNJ-28431754) in healthy Indian volunteers.
Key Dates
- Start date
- Aug 31, 2008
- Status verified
- Jul 2016
- Primary completion
- Sep 30, 2008
- Completion
- Sep 30, 2008
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment AEach volunteer will receive a single 200 mg dose of canagliflozin (JNJ-28431754) on Day 1.
- Experimental: Treatment BEach volunteer will receive a single 300 mg dose of canagliflozin (JNJ-28431754) on Day 1.
Primary Outcome Measure
Plasma concentrations of canagliflozin JNJ-28431754) [ Time Frame: Up to Day 4 ]
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