Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a therapeutic agent for Non-Small Cell Lung Cancer.
This clinical trial will be conducted in healthy Korean and Caucasian volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center. It is expected to take approximately 39 days from the first dosing of Investigational Product until the final follow-up visit. It will be hospitalized twice for 9 nights and 10 days with 21 days of interval, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
period 1: A single oral dose of YH25448 240 mg an overnight fast period 2: A single oral dose of YH25448 240 mg after a high-fat breakfast
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea
AUClast of YH25448
Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448
Time frame: 0-192 hrs
Cmax of YH25448
Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448
Time frame: 0-192 hrs
AUCinf of YH25448
Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448
Time frame: 0-192 hrs
Tmax of YH25448
Time to reach Cmax of YH25448
Time frame: 0-192 hrs
t1/2 of YH25448
Terminal half life (t1/2) of YH25448
Time frame: 0-192 hrs
CL/F of YH25448
The apparent plasma clearance (CL/F) of YH25448
Time frame: 0-192 hrs
Vd/F of YH25448
Apparent Volume of distribution of YH25448
Time frame: 0-192 hrs
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