Primary objective \- To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition. Secondary objectives * To explore food effect on the pharmacodynamics (PD) of single oral dose of HIP1601 in healthy subjects under fed or fasting condition. * To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Single dosing of HIP1601 40mg, orally
Seoul National University Biomedical Research Institute
Seoul, South Korea
Cmax
Maximum observed concentration after dose
Time frame: Blood sampling during 24 hours after administration
Area Under the plasma concentration versus time Curve(AUC)last
Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration
Time frame: Blood sampling during 24 hours after administration
Tmax
Time of Cmax over the time span specified
Time frame: Blood sampling during 24 hours after administration
AUCinf
Area under the plasma concentration versus time curve from the time of dosing to time extrapolated to infinitely
Time frame: Blood sampling during 24 hours after administration
t1/2
Terminal half-life
Time frame: Blood sampling during 24 hours after administration
Clearance/F
Apparent total body clearance after extravascular administration, calculated as Dose/AUCinf
Time frame: Blood sampling during 24 hours after administration
Vd/F
Apparent volume of distribution after extravascular administration, calculated as Dose/(λzㆍAUCinf)
Time frame: Blood sampling during 24 hours after administration
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