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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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. |
|
| Group 2 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lazertinib(G001) | Drug | Current formulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of YH25448 | Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448 | 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 | 0 - 168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-72h of YH25448 | Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448 | 0 - 72 hours |
| AUCinf of YH25448 | Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development and Medical Department | Yuhan Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Lazertinib(G002) |
| Drug |
New formulation |
|
| 0 - 168 hours |
| Tmax of YH25448 | Time to reach Cmax of YH25448 | 0 - 168 hours |
| t1/2 of YH25448 | Terminal half life (t1/2) of YH25448 | 0 - 168 hours |
| λz of YH25448 | Terminal rate constant of YH25448 | 0 - 168 hours |
| CL/F of YH25448 | The apparent plasma clearance (CL/F) of YH25448 | 0 - 168 hours |
| Vd/F of YH25448 | Apparent Volume of distribution of YH25448 | 0 - 168 hours |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |