The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers
- Registration Number
- NCT01343290
- Brief Summary
The purpose of this study is to assess the effect of food on the absorption of canagliflozin in the body when canagliflozin is taken with and without food by healthy volunteers
- Detailed Description
This is a single-center, single-dose, open-label (volunteers will know the identity of assigned treatment), randomized (one of 2 study drug sequences assigned by chance) study to evaluate the oral bioavailability (the degree to which the drug is absorbed in the body when taken orally by mouth) of canagliflozin when taken with and without food in healthy volunteers. Healthy Volunteers will take 1 canagliflozin tablet orally for 1 day in 2 treatment periods (canagliflozin will be taken with food in 1 treatment period and canagliflozin will be taken without food in 1 treatment period); the 2 treatment periods will be separated by a 10- to 14-day washout period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg
- of or current medical illness deemed clinically significant by the Investigator (study physician)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 001 Canagliflozin Canagliflozin Type = 1 unit = mg number = 300 form = tablet route = oral use. Single tablet taken with or without a meal during 2 treatment periods
- Primary Outcome Measures
Name Time Method Concentration of canagliflozin in plasma samples For up to 8 days
- Secondary Outcome Measures
Name Time Method Adverse events reported Up to approximately 34 days Vital signs measurements Up to approximately 34 days Results from clinical chemistries performed Up to approximately 34 days Results from 12-lead ECGs performed Up to approximately 34 days