Study in healthy subjects to measure amount of drug in blood after dosing with different saxagliptin / metformin products.
Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Oral tablets, 5 mg , single dose
Extended release oral tablets, 1000 mg, single dose
Extended release fixed dose combination tablet, single dose
Research Site
Overland Park, Kansas, United States
PK Saxagliptin: Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Time frame: At day 5 to day 6 at visit 2 or 3
PK : Metformin Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Time frame: At day 5 to day 6 at visit 2 or 3
PK : Saxagliptin 5-hydroxy Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Time frame: At day 5 to day 6 at visit 2 or 3
Safety will be assessed by the incidence, severity, and relatedness of adverse events.
Time frame: From day -1 visit 2 until performed follow up ( Approximately 30 days)
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Extended release oral tablets, 500 mg, single dose
Extended release fixed dose combination tablet, single dose