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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02039245

Run by

Janssen Research & Development, LLC

People needed

12

Starts

2014-01-01

Expected to finish

2014-03-01

Last updated by the study team

2014-04-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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