Healthy
Conditions
Keywords
Canagliflozin, Rifampin, Pharmacokinetics
Brief summary
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.
Detailed description
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.
Interventions
DRUGRifampin
Type=2, unit=mg, number=300, Form=capsule, route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.
DRUGCanagliflozin
Type=1, unit=mg, number=300, form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive)
Exclusion criteria
* History of or current medical illness deemed clinically significant by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of canagliflozin | Day 1 up to Day 13 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of Rifampin | Day 9 up to Day 13 |
| Adverse events reported | For approximately 13 days |
Countries
United States
Outcome results
None listed