Overview

Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination

Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2 Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150 mg/1,000 mg each) following once-daily oral dosing 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 systemic prescription or nonprescription medication (including vitamins and
herbal supplements)

- Known allergy to canagliflozin or metformin or any of the excipients of the
formulation

- Known allergy to heparin or history of heparin induced thrombocytopenia

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