Overview

A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin Extended Release Tablet Coadministered With Canagliflozin in Healthy Fed a

Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet coadministered with canagliflozin in healthy fed and fasted participants.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Canagliflozin
Metformin
Criteria
Inclusion Criteria:

- Contraceptive use by men or women should be consistent with local regulations
regarding the use of contraceptive methods for participant participating in clinical
studies

- Before randomization, a woman must be either Not of childbearing potential or of
childbearing potential and agrees to use a highly effective method of contraception
(failure rate of less than [<]1 percent [%] per year when used consistently and
correctly) throughout the study

- All women must have a negative urine pregnancy test at Screening and on Day -1 of each
Treatment Period

- Body mass index (BMI) (weight [kg]/height^2 [m]^2) between 18 and 30 kg/m^2
(inclusive), and body weight not less than 50 kg

- Blood pressure (an average of 3 measurements done after the participant is sitting for
5 minutes and with at least 5 minutes between measurements) between 90 and 140
(mercury of millimeter) mmHg, inclusive, systolic and no higher than 90 mmHg diastolic
at Screening or Day -1 of each Treatment Period

- Normal renal function evidenced by estimated glomerular filtration rate (eGFR) greater
than or equal to (>=90) milliliters per minute (mL/min)/1.73m^2 using the Modification
of Diet in Renal Disease Study (MDRD) equation as defined in the protocol

Exclusion Criteria:

- History of or current clinically significant medical illness including (but not
limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid
abnormalities, significant pulmonary disease, including bronchospastic respiratory
disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease,
neurologic or psychiatric disease, infection, or any other illness that the
investigator considers should exclude the participant or that could interfere with the
interpretation of the study results

- Clinically significant abnormal values for hematology, clinical chemistry, or
urinalysis as assessed by the investigator at Screening or Day -1 of the first
Treatment Period

- Clinically significant abnormal physical examination, vital signs, or 12 lead
electrocardiogram (ECG) (Screening only) as assessed by the investigator at Screening
or on Day -1 of the first Treatment Period as deemed appropriate by the investigator

- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements), except for acetaminophen, hormonal contraceptives and hormonal
replacement therapy within 14 days before the first dose of the study drug is
scheduled

- History of, or a reason to believe a participant has a history of drug or alcohol
abuse within the past 5 years