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

Janssen Research & Development, LLC74 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Treatment A: Canagliflozin tabletDRUG

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.

Treatment A: Metformin IR tabletsDRUG

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.

Treatment B: Canagliflozin/metformin fixed dose combination tabletsDRUG

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Canagliflozin plasma concentrations

Time frame: Up to 72 hours

Metformin plasma concentrations

Time frame: Up to 72 hours

Secondary Outcomes

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).

Time frame: Up to approxmately 23 days

Changes from baseline in clinical laboratory test results

Time frame: Up to approximately 23 days

Vital Signs

Blood pressure, pulse, and oral body temperature

Time frame: Up to approximately 23 days

Data from ClinicalTrials.gov

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