To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
40
Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose
Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose
Metformin 500mg, oral, single dose
Unnamed facility
Seoul, South Korea
Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
Time frame: within 4 hours after sucrose load
Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
Time frame: within 4 hours after sucrose load
Cmax of metformin
Time frame: within 24 hours after dosing
AUC(0-tn) of metformin
Time frame: within 24 hours after dosing
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