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

A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagl

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States

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 18.5 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	Drug: A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets); Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 850, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/850, form = tablet, route = oral use. Two canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2
Experimental: Treatment Sequence BA	Drug: B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets); Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/850, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 850, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Vital signs	Blood pressure, pulse, and oral body temperature	Up to approximately 23 days
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
Clinical laboratory tests	Clinically relevant changes occurring in laboratory safety parameters	Up to approxmately 23 days

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Investigators: Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: December 23, 2011
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Estimate): August 29, 2012
• Last Update Submitted That Met QC Criteria: August 28, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Volunteers; Canagliflozin (JNJ-28431754); Metformin IR
• 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: CR100681; 28431754DIA1052 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)