The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (canagliflozin and metformin IR).
This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.
Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.
Unnamed facility
Tempe, Arizona, United States
Canagliflozin plasma concentrations
Time frame: Up to 72 hours in Treatment Period 1 and Treatment Period 2
Metformin plasma concentrations
Time frame: Up to 24 hours in Treatment Period 1 and Treatment Period 2
Changes in clinical laboratory test values
Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Changes in vital signs measurements
Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Changes in electrocardiogram (ECG) parameters
Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Changes in physical examination results
Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
The number of patients reporting adverse events
Time frame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
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Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
Type = 2, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.