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 XR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:12/7/2016
Start Date:August 2016
End Date:October 2016

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A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) 1 x (150 mg/500 mg) With Respect to the Metformin XR Tablet (Locally Sourced From Canada [GLUMETZA, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 100 mg + 1 x 50 mg) in Healthy Fed and Fasted Subjects

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
co-administered with canagliflozin in healthy fed and fasted participants.


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 kilogram (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
mmHg, inclusive, systolic and no higher than 90 (Millimeter of mercury) mmHg
diastolic at Screening or Day -1 of each Treatment Period

- Normal renal function evidenced by estimated glomerular filtration rate (eGFR) >=90
mL/min/1.73m2 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
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