Pharmacokinetics of a Fixed Dose Combination of Canagliflozin/Metformin Coadministered With Food

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effect of coadministration of a high-fat meal on the oral bioavailability of a fixed dose combination of Canagliflozin/extended release Metformin (CANA/MET XR) tablet, containing 150 mg CANA and 1,000 mg extended release MET in healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Canagliflozin; Metformin

Criteria

Inclusion Criteria:

• Must sign an informed consent document indicating they understand the purpose of the study and procedures

• Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive

• Must have a body weight of not less than 50 kg

• Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening

• Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)

Exclusion Criteria:

• History of or current clinically significant medical illness

• Use of any prescription or nonprescription medication (including vitamins and herbal supplements)

• History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose- Known allergy to heparin or history of heparin induced thrombocytopenia

• History of smoking or use of nicotine-containing substances within the previous 2 months