This study is designed to evaluate dose-proportionality of Dilatrend SR 8mg, 16mg, 32mg, 64mg, 128mg in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
single oral administration in period 1 or 2, 3 for each sequential group.
Asan Medcial Center
Songpa-gu, Seoul, South Korea
Dose-proportionality
AUClast
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
AUC0-∞
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
Cmax
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
Tmax
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Dose-proportionality
t½β
Time frame: 0(predose), 1, 2, 4, 5, 6, 8, 12, 16, 24, 36 and 48h
Safety
Adverse Event/Serious Adverse Event monitoring Physical Examination, Vital Sign, 12-lead ECG, Lab Tests
Time frame: 0(predose), 4, 8, 12, 24, 36, 48h and follow-up visit(22d±1d)
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