NCT01395927

A Study to Evaluate the Effects of Rifampin on Single-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

An Open-Label, Fixed-Sequence Study to Assess Effects of Steady-State Rifampin on the Single-Dose Pharmacokinetics of Canagliflozin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rifampin	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

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-07-18
• Last updated: 2013-05-06

Locations

1 site across 1 country: United States