A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (canagliflozin and metformin IR).

Detailed Description
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This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a washout period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.

Official Title
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A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 500 mg) in Healthy Fed Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Canagliflozin tablets
* Drug: Metformin IR tablets
* Drug: Canagliflozin/metformin IR FDC tablets
* Drug: Canagliflozin/metformin IR FDC tablets
* Drug: Canagliflozin tablets
* Drug: Metformin IR tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg Exclusion Criteria: History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead ECG deemed to be clinically significant by the Investigator

Ages Eligible for Study
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Minimum Age: 19 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence AB<br>Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 1 followed by Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods. | Drug: Canagliflozin tablets<br>* Type = exact number, unit = mg, number = 100, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.<br>* Other names: Treatment A (Reference);Drug: Metformin IR tablets<br>* Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.<br>* Other names: Treatment A (Reference);Drug: Canagliflozin/metformin IR FDC tablets<br>* Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.<br>* Other names: Treatment B (Test);|
| Experimental: Treatment Sequence BA<br>Treatment B (canagliflozin/metformin IR FDC tablets) administered on Day 1 of Treatment Period 1 followed by Treatment A (canaglifozin + metformin IR tablets) administered on Day 1 of Treatment Period 2 with a washout period of 10-15 days between treatment periods. | Drug: Canagliflozin/metformin IR FDC tablets<br>* Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.<br>* Other names: Treatment B (Test);Drug: Canagliflozin tablets<br>* Type = exact number, unit = mg, number = 100, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.<br>* Other names: Treatment A (Reference);Drug: Metformin IR tablets<br>* Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.<br>* Other names: Treatment A (Reference);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canagliflozin plasma concentrations |  | Up to 72 hours in Treatment Period 1 and Treatment Period 2 | 
| Metformin plasma concentrations |  | Up to 24 hours in Treatment Period 1 and Treatment Period 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in clinical laboratory test values |  | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) | 
| Changes in vital signs measurements |  | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) | 
| Changes in electrocardiogram (ECG) parameters |  | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) | 
| Changes in physical examination results |  | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) | 
| The number of patients reporting adverse events |  | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Bioequivalence, Canagliflozin (JNJ-28431754), Metformin IR