The purpose of this study is to see if the absorption and distribution of a fixed-dose
Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food
by healthy volunteers.
Drug: A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state)
Drug: B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state)
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Full eligibility criteria for NCT01459094
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
- Body mass index (BMI) between 18 and 30 kg/m² inclusive and a body weight of not less than 50 kg.
- History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
All locations for NCT01459094
View full eligibility
Tris trial is registered with FDA with number: NCT01459094. The sponsor of the trial is Janssen Research & Development, LLC and it is looking for 24 volunteers for the current phase.
Official trial title: Single-Dose, Open-Label, Randomized, 2-Period Crossover Study to Assess the Effect of Food Coadministration on the Pharmacokinetics of a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Subjects
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