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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rifampin
* Drug: Canagliflozin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>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. | Drug: Rifampin<br>* Type=2, unit=mg, number=300, Form=capsule, route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.<br>Drug: Canagliflozin<br>* Type=1, unit=mg, number=300, form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of canagliflozin |  | Day 1 up to Day 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of Rifampin |  | Day 9 up to Day 13 | 
| Adverse events reported |  | For approximately 13 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Canagliflozin, Rifampin, Pharmacokinetics