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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CANA/MET XR FDC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canagliflozin/Metformin XR<br>Each patient will receive 2 tablets of CANA/MET XR combination of total dose 300/2000 mg | Drug: CANA/MET XR FDC<br>* Each tablet contains Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) of 150 mg/1,000 mg, to be taken orally (by mouth)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets | Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body. | Day 1, Day 7 | 
| Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets | Plasma concentrations of metformin are used to evaluate how long it stays in the body. | Day 1, Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with adverse events as a measure of safety and tolerability |  | Screening, up to Day 10 of the follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Canagliflozin, Metformin, INVOKANA®, Type 2 Diabetes Mellitus