The purpose of this study is to evaluate the bioequivalence of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and fasted participants.
This is a randomized (study medication assigned to participants by chance), open-label (identity of study drug will be known to volunteer and study staff), single-center, single-dose, 4-treatment, 4-way crossover (method used to switch participants from one study group to another in a clinical trial, like the flip of a coin) study in healthy adult participants. The study will have 3 phases: Screening Phase (approximately 3 weeks, Day -22 to Day -2), Open-Label Treatment Phase (consisting of 4 single-dose treatment periods of 3 days each \[Day -1 to Day 2\], each separated by a washout period of 7 days) and Follow-up Phase (5 to 7 days after last study-related procedure on Day 2 of treatment period 4). All the eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive 2 treatments under fasting and 2 treatments under fed conditions. Blood samples will be collected for evaluation of pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) at pre-dose and post-dose of study treatment. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Participants will receive 1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed or fasted condition in each treatment period as per treatment sequence.
Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablet) under fed or fasted condition in each treatment period as per treatment sequence.
Participants will receive metformin 500 mg tablet orally under fed or fasted condition in each treatment period as per treatment sequence.
Unnamed facility
Lincoln, Nebraska, United States
Plasma Concentration of Metformin
Plasma concentrations of metformin are used to evaluate how much metformin is in the blood over time.
Time frame: Pre-dose, up to 24 hours afterdose
Plasma Concentration of Canagliflozin
Plasma concentrations of canagliflozin are used to evaluate how much canagliflozin is in the blood, 2 hours after dosing.
Time frame: 2 hours after dosing
Adverse Events
The number and type of adverse events will be reported from Day 1 of treatment period 1 through 5-7 days after treatment period 4 including a 7+/- 1 day washout period between treatment periods (total time is approximately 58 days).
Time frame: Up to approximately 58 days
Clinical Laboratory Test
Clinically relevant changes occurring in laboratory safety parameters will be evaluated.
Time frame: Up to approximately 58 days
Vital Signs
Blood pressure, pulse, and oral body temperature will be evaluated.
Time frame: Up to approximately 58 days
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