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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02039258

Run by

Janssen Research & Development, LLC

People needed

24

Starts

2014-01-01

Expected to finish

2014-03-01

Last updated by the study team

2014-07-14

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 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

Where it is running

• Study site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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