A Study to Evaluate the Effects of Rifampin on Single-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Open-Label, Fixed-Sequence Study to Assess Effects of Steady-State Rifampin on the Single-Dose Pharmacokinetics of Canagliflozin in Healthy Subjects|
- Plasma concentrations of canagliflozin [ Time Frame: Day 1 up to Day 13 ] [ Designated as safety issue: No ]
- Plasma concentrations of Rifampin [ Time Frame: Day 9 up to Day 13 ] [ Designated as safety issue: No ]
- Adverse events reported [ Time Frame: For approximately 13 days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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.
Type=2, unit=mg, number=300, Form=capsule, route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.Drug: Canagliflozin
Type=1, unit=mg, number=300, form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10
This is an open-label (volunteer and study staff will know the identity of study drugs assigned) study of canagliflozin and rifampin taken in a sequential order by healthy volunteers for up to 12 days. Healthy volunteers will take orally (by mouth) one 300 mg canagliflozin tablet and/or two 300 mg rifampin capsules daily in sequential order as follows: on Day 1 volunteers will take one 300-mg canagliflozin tablet, on Days 4 to 9 volunteers will take two 300-mg rifampin capsules once daily, on Day 10 volunteers will take one 300-mg canagliflozin tablet + two 300-mg rifampin capsules, and on Days 11 and 12 volunteers will take two 300-mg rifamplin capsules once daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395927
|United States, Kansas|
|Overland Park, Kansas, United States|
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|