safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
24
1. multiple dosing 2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
Samsung medical center
Seoul, Seoul, South Korea
Safety and tolerability
through physical examination, laboratory result, vital sign,ECG etc.
Time frame: throughout the study up to day 28
Efficacy(IELT)
change from baseline in IELT at the Day 13, 28
Time frame: 13days, 28days
Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F
Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt will be assessed. Samping time point: intensive sampling(Day1\~2, Day14\~15)\& intermittent sampling(Day3\~Day 28 except intensive sampling period)
Time frame: specified timepoints in the protocol
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