Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination
- Conditions
- Healthy Volunteers
- Interventions
- Drug: CANA/MET XR FDC
- Registration Number
- NCT02039245
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Canagliflozin/Metformin XR CANA/MET XR FDC Each patient will receive 2 tablets of CANA/MET XR combination of total dose 300/2000 mg
- Primary Outcome Measures
Name Time Method Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets Day 1, Day 7 Plasma concentrations of metformin are used to evaluate how long it stays in the body.
Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets Day 1, Day 7 Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
- Secondary Outcome Measures
Name Time Method Percentage of participants with adverse events as a measure of safety and tolerability Screening, up to Day 10 of the follow-up