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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
44
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.
Participants will receive canagliflozin 50 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Unnamed facility
Tempe, Arizona, United States
Maximum Observed Plasma Concentration (Cmax) of Metformin
The Cmax is the maximum observed plasma concentration of metformin.
Time frame: 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).
Time frame: 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.
Time frame: 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
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Day -1 to End of study (up to 58 Days)
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