A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin IR Tablets (2 x 850 mg) in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets); Drug: B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)

• Registration Number: NCT01518712
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

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 canagliflozin and metformin IR.

Detailed Description

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 IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as fixed-dose combination (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 Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2011-12-23
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-28
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence AB	A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets)	-
Treatment Sequence BA	B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)	-

Primary Outcome Measures

Name	Time	Method
Canagliflozin plasma concentrations	At 15 time points up to 72 hours
Metformin plasma concentrations	At 13 time points up to 24 hours

Secondary Outcome Measures

Name	Time	Method
Adverse events	Up to approxmately 23 days	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).
Clinical laboratory tests	Up to approxmately 23 days	Clinically relevant changes occurring in laboratory safety parameters
Vital signs	Up to approximately 23 days	Blood pressure, pulse, and oral body temperature