Seoul National University Hospital Clinical Trial Center
Seoul, South Korea
NCT Number: NCT03556436
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.
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Notify Me19 year–55 year
Male
Interventional
Phase 1
Seoul, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: YH25448
Time frame: 0-192 hrs
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
Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448
Time frame: 0-192 hrs
Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448
Time frame: 0-192 hrs
Time to reach Cmax of YH25448
Time frame: 0-192 hrs
Terminal half life (t1/2) of YH25448
Time frame: 0-192 hrs
The apparent plasma clearance (CL/F) of YH25448
Time frame: 0-192 hrs
Apparent Volume of distribution of YH25448
Yuhan Corporation
Industry
An Open-label, Single-dose Phase 1 Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448 in Healthy Korean and Caucasian Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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