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Lazertinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants first received lazertinib(G001) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14\~21days, they then received lazertinib(G002) 240mg in a fasting state morning for 1 day.

Participants first received lazertinib(G002) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14\~21days, they then received lazertinib(G001) 240mg in a fasting state morning for 1 day.

Lazertinib(G001)

Lazertinib(G002)

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.

Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.

An Open-label, Randomized, Fasted, Single-dose, Oral Administration, 2-sequence, 2-period Crossover Study to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Adult Volunteers

Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448

Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448

Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448

The apparent plasma clearance (CL/F) of YH25448

Apparent Volume of distribution of YH25448

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.	NCT05162274	Healthy Adult V...	Lazertinib(G001... Lazertinib(G002...	19 Years -	Yuhan Corporation
Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.	NCT05162274	Healthy Adult V...	Lazertinib(G001... Lazertinib(G002...	19 Years -	Yuhan Corporation

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