A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR 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 a fixed dose combination tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of 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 of canagliflozin and metformin when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin) (Treatment A) and when administered as a fixed dose combination tablet (ie, canagliflozin and metformin in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

Official Title
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Pivotal BE CANA/MET IR FDC - Low Strength

Conditions
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Healthy

Intervention / Treatment
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* Drug: Treatment A: Canagliflozin tablet
* Drug: Treatment A: Metformin IR tablets
* Drug: Treatment B: Canagliflozin/metformin fixed dose combination 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 electrocardiogram (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>The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days. | Drug: Treatment A: Canagliflozin tablet<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 A.<br>Drug: Treatment A: Metformin IR tablets<br>* Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.<br>Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets<br>* Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.<br>|
| Experimental: Treatment Sequence BA<br>The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days. | Drug: Treatment A: Canagliflozin tablet<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 A.<br>Drug: Treatment A: Metformin IR tablets<br>* Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.<br>Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets<br>* Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.<br>|

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 | 
| Metformin plasma concentrations |  | Up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | The number and type of adverse events will be reported from Day 1 of treatment period 1 through 7-10 days after treatment period 2 including the 10-15 washout period between treatment periods (total time is approximately 23 days). | Up to approxmately 23 days | 
| Changes from baseline in clinical laboratory test results |  | Up to approximately 23 days | 
| Vital Signs | Blood pressure, pulse, and oral body temperature | Up to approximately 23 days | 

 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