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

Pivotal BE CANA/MET IR FDC - Low Strength

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Treatment A: Canagliflozin tablet; Drug: Treatment A: Metformin IR tablets; Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets

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 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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence AB; 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; 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.; Drug: Treatment A: Metformin IR tablets; 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.; Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets; 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.
Experimental: Treatment Sequence BA; 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; 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.; Drug: Treatment A: Metformin IR tablets; 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.; Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 20, 2011
• First Submitted That Met QC Criteria: November 1, 2011
• First Posted (Estimate): November 2, 2011

Study Record Updates

• Last Update Posted (Estimate): November 21, 2012
• Last Update Submitted That Met QC Criteria: November 20, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Metformin; Bioequivalence; Healthy Volunteers; Canagliflozin (JNJ-28431754)
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Metformin; Canagliflozin
• Other Study ID Numbers: CR100674; 28431754DIA1039 (Other Identifier: Janssen Research & Development, LLC)