This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.
Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.
Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.
Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin
Serum samples were used to determine the AUC from time 0 to infinity for metformin.
Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose
Peak Plasma Concentration (Cmax) of Metformin
Serum samples were used to determine the maximum concentration for metformin.
Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose
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