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A Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers

Healthy Clinical Trial

Official title:
An Open-Label, Single-Dose, Randomized, 3-Period, Crossover Study to Evaluate the Pharmacokinetic Dose Proportionality of Canagliflozin of 50, 100, and 300 mg Under Fasted Conditions in Healthy Subjects

Clinical Trial Summary

The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of canagliflozin in healthy volunteers.

Clinical Trial Description

This is an open-label study where healthy volunteers will know the name and dose of assigned treatment and will be randomly assigned to take a single oral (by mouth) dose of canagliflozin sequentially in each of 3 treament periods where the dose in each treatment period will be different (referred to as a 3-period crossover study) to evaluate the pharmacokinetics (blood levels) of 3 dose levels of canagliflozin. Healthy volunteers will take a single oral tablet of canagliflozin 50 mg (Treatment A), 100 mg (Treatment B), and 300 mg (Treatment C) during the study; a different dose will be taken in each treatment period. Study drug will be taken in the a.m. on Day 1 of Treatment Periods 1, 2, and 3, with a 10- to 14-day washout period between Day 1 of each treatment period. Volunteers will fast (go without food) for at least 10 hours before and up to at least 4 hours after taking study drug. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01340677
Study type Interventional
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status Completed
Phase Phase 1
Start date May 2011
Completion date August 2011
View Details
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