Effect of Food on a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state); Drug: B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state)

• Registration Number: NCT01459094
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to see if the absorption and distribution of a fixed-dose Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food by healthy volunteers.

Detailed Description

This is an open-label (identity of study drug will be known to volunteers and study staff), single-center study to evaluate the oral bioavailability (ie, absorption and distribution within the body) and pharmacokinetics (blood levels) of a single dose of 1 fixed-dose combination (FDC) tablet of canagliflozin and metformin IR (abbreviated as 1 CANA/MET IR FDC tablet) when taken by healthy volunteers without food (in a fasting state) or with food (in a fed state). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fasting state) followed approximately 14 days later by Treatment B (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fed state) or Treatment B followed approximately 14 days later by Treatment A.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-10-21
• Study First Posted: 2011-10-25
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-18
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Body mass index (BMI) between 18 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence AB	A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state)	-
Treatment Sequence BA	B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state)	-

Primary Outcome Measures

Name	Time	Method
Canagliflozin plasma concentrations	Up to 72 hours
Metformin plasma concentrations	Up to 24 hours

Secondary Outcome Measures

Name	Time	Method
Adverse events	Up to approximately 22 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 10-14 day washout period between treatment periods (total time is approximately 22 days).
Clinical Laboratory Tests	Up to approximately 22 days	Clinically relevant changes from baseline occurring in laboratory safety parameters
Vital Signs	Up to approximately 22 days	Changes from baseline in blood pressure and pulse