This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers. The subjects administer 240mg of lazertinib of different formulations on the fasted status on each period and have a wash-out period for 14-21 days between the first and second period.
This clinical trial will be conducted in healthy male volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center. It is expected to take approximately 32 days from the first dosing of Investigational Product until the final follow-up visit. Subjects will be hospitalized twice for 4 nights and 5 days with 7-14 days of wash-out period, 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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Current formulation
New formulation
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 - 168 hours
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 - 168 hours
AUC0-72h 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 - 72 hours
AUCinf of YH25448
Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448
Time frame: 0 - 168 hours
Tmax of YH25448
Time to reach Cmax of YH25448
Time frame: 0 - 168 hours
t1/2 of YH25448
Terminal half life (t1/2) of YH25448
Time frame: 0 - 168 hours
λz of YH25448
Terminal rate constant of YH25448
Time frame: 0 - 168 hours
CL/F of YH25448
The apparent plasma clearance (CL/F) of YH25448
Time frame: 0 - 168 hours
Vd/F of YH25448
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Apparent Volume of distribution of YH25448
Time frame: 0 - 168 hours