1. Study Objective: The objective of this clinical trial is to investigate the effect of food on the pharmacokinetics of HSG4112 after oral administration in healthy male subjects. 2. Study Design and Plan: This study is a randomized, open-label, single dose, 3-way crossover clinical trial. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. A total of 12 subjects will be randomized to 6 different sequence groups. Each subject will receive a single dose of HSG4112 480 mg via oral administration under fasted, low-fat diet, and high-fat diet conditions, with a washout period of 21 days in between each dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Once-daily oral administration
Seoul National University Hospital
Seoul, South Korea
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval
Area under the plasma concentration-time curve of HSG4112 over dosing interval (AUCtau)
Time frame: Hour 0 to 24
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point
Area under the plasma concentration-time curve from time zero to the last measurable point (AUClast)
Time frame: Hour 0 to 192
Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112
Maximum plasma concentration of HSG4112 (Cmax)
Time frame: Hour 0 to 192
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: Hour 0 to 192
Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112
Time to maximum observed plasma concentration of HSG4112 (Tmax)
Time frame: Hour 0 to 192
Pharmacokinetic Assessment by Half-Life of HSG4112
Half-life of HSG4112 (T1/2)
Time frame: Hour 0 to 192
Pharmacokinetic Assessment by Oral Clearance of HSG4112
Oral clearance of HSG4112 (CL/F)
Time frame: Hour 0 to 192
Pharmacokinetic Assessment by Volume of Distribution of HSG4112
Volume of distribution of HSG4112 (Vd/F)
Time frame: Hour 0 to 192
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