Healthy
Conditions
Brief 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.
Interventions
Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 500 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.
DRUGCanagliflozin
Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
Participants will receive 1 metformin XR tablet of 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 between 90 and 140 millimeter of mercury (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) \>=90 milliliters per minute (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Metformin | Predose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr postdose on Day 1; 24 hr postdose on Day 2 | The Cmax is the maximum observed plasma concentration of metformin. |
| Area Under the Plasma Concentration Time Curve From Time 0 to The Time of the Last Observed Quantifiable Concentration (AUClast) of Metformin | Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2 | The AUClast is the area under the plasma concentration time curve from time 0 to the time of the last observed quantifiable concentration (Clast). |
| Area Under the Plasma Concentration Time Curve From Time 0 to Infinite Time [AUC (0-infinity)] of Metformin | Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2 | The AUC (0-infinity) is the area under the plasma concentration time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | Screening to End of study (up to 58 Days) |
Countries
United States
Outcome results
None listed