Study to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics(PK/PD)of YH12852 after oral administration in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
127
Inje Busan Paik hospital
Busan, South Korea
the number of adverse events, seriousness of adverse event
Time frame: D1~Post study visit
significant changes in vital sign
Time frame: D1~Post study visit
significant changes in 12-lead electrocardiography
Time frame: D1~Post study visit
significant changes in laboratory test
Time frame: D1~Post study visit
significant physical exam
Time frame: D1~Post study visit
Cmax
Time frame: 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort)
AUC
Time frame: 0~48 hrs(SAD,FSD cohorts), 0~24 hrs/D5,6 0hr/D7 0~48hrs(MAD cohort)
Ae
Time frame: 0~48 hrs(SAD cohort), 0~24 hrs/D7 0~48hrs(MAD cohort)
BSFS
pharmacodynamics
Time frame: D1~7(SAD, FSD cohorts), D1~14(MAD cohort)
Frequency of defecation
pharmacodynamics
Time frame: D1~7(SAD, FSD cohorts), D1~14(MAD cohort)
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