A Study to Assess the Bioequivalence of the Metformin Com... | NCT02846506

NCT02846506

ID	Type	Description	Link
28431754DIA1075	Other Identifier	Janssen Research & Development, LLC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Sequence ADBC	Experimental	Participants will receive Treatment A (1 canagliflozin tablet 100 milligram (mg) and 1 canagliflozin tablet 50 mg along with 1 Extended Release (XR) tablet of metformin 500 mg orally under fed condition) on Day 1 of treatment period 1, then Treatment D (1 XR fixed dose combination [FDC] tablet containing canagliflozin 150 mg and metformin 500 mg orally under fasted condition) on Day 1 of treatment period 2, then Treatment B (1 XR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed condition) on Day 1 of treatment period 3, followed by Treatment C (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg and metformin (XR) 500 mg orally under fasted condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.	Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC] Drug: Canagliflozin 50 mg Drug: Canagliflozin 100 mg Drug: Metformin Extended Release (XR)
Treatment Sequence BACD	Experimental	Participants will receive Treatment B on Day 1 of treatment period 1, then Treatment A on Day 1 of treatment period 2, then Treatment C on Day 1 of treatment period 3, followed by Treatment D on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.	Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC] Drug: Canagliflozin 50 mg Drug: Canagliflozin 100 mg Drug: Metformin Extended Release (XR)
Treatment Sequence CBDA	Experimental	Participants will receive Treatment C Day 1 of treatment period 1, then Treatment B on Day 1 of treatment period 2, then Treatment D on Day 1 of treatment period 3, followed by Treatment A on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]	Drug	Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Metformin	The Cmax is the maximum observed plasma concentration 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
Area Under the Plasma Concentration-Time Curve From Time 0 to The Time of the Last Observed Quantifiable Concentration (AUClast) of Metformin	The AUClast is the area under the plasma concentration-time curve from time 0 to the time of the last observed quantifiable concentration (Clast).	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
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time [AUC (0-infinity)] of Metformin	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.	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

Measure	Description	Time Frame
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability		Day -1 to End of study (up to 58 Days)

Eligibility Module

Eligibility 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 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

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates