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

Single-Dose, Open-Label, Randomized, 2-Period Crossover Study to Assess the Effect of Food Coadministration on the Pharmacokinetics of a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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)

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Sequence AB	Drug: A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state); Treatment A: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally (by mouth) in a fasting state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 2.
EXPERIMENTAL: Treatment Sequence BA	Drug: B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state); Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fasting state on Day 1 of Treatment Period 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Canagliflozin plasma concentrations	Up to 72 hours
Metformin plasma concentrations	Up to 24 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 10-14 day washout period between treatment periods (total time is approximately 22 days).	Up to approximately 22 days
Clinical Laboratory Tests	Clinically relevant changes from baseline occurring in laboratory safety parameters	Up to approximately 22 days
Vital Signs	Changes from baseline in blood pressure and pulse	Up to approximately 22 days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Publications and helpful links

General Publications

• Murphy J, Wang SS, Stieltjes H, Wajs E, Devineni D. Effect of food on the pharmacokinetics of canagliflozin/metformin (150/1,000 mg) immediate-release fixed-dose combination tablet in healthy participants. Int J Clin Pharmacol Ther. 2015 Mar;53(3):256-64. doi: 10.5414/CP202233.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: October 21, 2011
• First Posted (ESTIMATE): October 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 18, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Canagliflozin (JNJ-28431754); Metformin IR; Oral bioavailability
• Other Study ID Numbers: CR100652; 28431754DIA1037 (OTHER: Janssen Research & Development, LLC)