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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:5/3/2014
Start Date:January 2014
End Date:March 2014
Email:JNJ.CT@sylogent.com

Use our guide to learn which trials are right for you!

An Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics of Canagliflozin (JNJ-28431754) and Metformin Following Once-Daily Administration of 2 Canagliflozin/Metformin XR (150/1,000-mg) Fixed Dose Combination Tablets in Healthy Subjects

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.

This is an open-label (physicians and participants know the identity of the assigned
treatment), multiple-dose, single-center, pharmacokinetic study of a fixed dose combination
(FDC) of 150 mg/1,000 mg Canagliflozin/extended release Metformin (CANA/MET XR) tablets. The
study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label
Treatment Phase, (when the participants will be confined to the study center for 11 days),
and a Follow-up Phase of about 10 days. The total duration of the study will be about 42
days for each participant. During the Open-Label Treatment Phase, approximately 12 healthy
adult participants will receive a single oral dose of 2 CANA/MET XR tablets once daily for 7
days after a provided dinner. Participants will be required to fast from the end of lunch
until the dinner (a period of at least 6.5 hours) on Days 1 and 7 only.

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
We found this trial at
1
site
?
mi
from
Neptune, NJ
Click here to add this to my saved trials