The pharmacokinetics of glimepiride and metformin will be compared after single dose intake of both combinations in order to answer to the following questions: * Is there a dose proportionality effect between Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg? * What is the safety profile of Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
33
single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group
single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group
Seoul National University Hospital
Seoul, South Korea
AUClast/D, Cmax/D
Time frame: pre-dose (=1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24 hrs after drug administration
Tmax, T1/2
Time frame: pre-dose (=1d 0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24 hrs after drug administration
Vital signs, ECG, physical examination, clinical laboratory tests
Time frame: screening, treatment period 1 & 2, Post-study visit
Adverse Event
Time frame: Treatment period 1 & 2, Post-study visit
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