Overview
Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination
Status:
Completed
Completed
Trial end date:
2014-03-01
2014-03-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Janssen Research & Development, LLCTreatments:
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