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 |
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.
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.
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
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