The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the
drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of
canagliflozin (JNJ-28431754) in healthy Indian volunteers.
Drug: Canagliflozin (JNJ-28431754) 200 mg
Drug: Canagliflozin (JNJ-28431754) 300 mg
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Full eligibility criteria for NCT01748526
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18 and 35 kg/m2 (inclusive) and body weight not less than 50 kg
Volunteer must have a glomerular filtration rate (the volume of fluid filtered by the kidney) more than or equal to 90 mL/min/1.73 m2 using the Modification of Diet in Renal Disease calculation
Fasting blood glucose at screening must be less than 100 mg/dL and the 2 hour plasma glucose following the oral glucose tolerance test (conducted at screening) must be less than 140 mg/dL
History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Female volunteer is breast-feeding
Volunteer has a history of smoking or use of nicotine-containing substances within the previous 2 months
All locations for NCT01748526
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Tris trial is registered with FDA with number: NCT01748526. The sponsor of the trial is Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and it is looking for 16 volunteers for the current phase.
Official trial title: A Single-Dose, Open-Label, Randomized, Two-Way, Cross-Over Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-28431754 in Healthy Indian Subjects
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