A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the bioequivalence (similarity of the drug amount in blood among the formulations) of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 150 mg/500mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metformin XR tablet (2 x 500 mg) in healthy fed 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 drugs or lactose

• Known allergy to heparin or history of heparin induced thrombocytopenia

• Donated blood or blood products or had substantial loss of blood within 3 months before screening