Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | YH25448 240mg single dose in korean |
|
| Group 2 | Experimental | YH25448 240mg single dose in caucasian |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH25448 240mg | Drug | 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 |
|
| 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 | 0-192 hrs |
| Cmax of YH25448 | Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448 | 0-192 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of YH25448 | Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448 | 0-192 hrs |
| Tmax of YH25448 | Time to reach Cmax of YH25448 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 0-192 hrs |
| t1/2 of YH25448 | Terminal half life (t1/2) of YH25448 | 0-192 hrs |
| CL/F of YH25448 | The apparent plasma clearance (CL/F) of YH25448 | 0-192 hrs |
| Vd/F of YH25448 | Apparent Volume of distribution of YH25448 | 0-192 hrs |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |