Study to Compare Pharmacokinetic Property of SYO-1644 Tab. and Nexavar Tab. in Healthy Male Volunteers

A Dose-block Randomized, Active-controlled, Open-label Clinical Study to Compare Pharmacokinetic Property of SYO-1644 Tab and Nexavar Tab in Healthy Male Volunteers

The purpose of this study is to evaluate the pharmacokinetics characteristics ,tolerability, and safety after orally administrating SYO-1644 to healthy male volunteers in randomized, active-controlled, open-label clinical study.

After orally administrating SYO-1644 and Nexavar 200 mg to healthy male participants , the safety, tolerability, and pharmacokinetic characteristics are to be compared while testing pharmacokinetic characteristics based on the dosage.

Inclusion Criteria:

1. Healthy male age between 19 and 50 years old at the time of screening

2. Healthy male more than or equal to 50 kg or less than or equal to 90 kg with BMI of 18~27

   • BMI(kg/m2) = Weight(kg) / {Height(m)}2

3. Agreement with written informed consent

Exclusion Criteria:

1. Participants with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary, psychiatric disorders or history
2. Participants with history of gastrointestinal ulcers, gastritis, gastric ulcer, gastroesophageal reflux disease, Crohn's disease, etc, that may affect the safety and pharmacokinetic evaluation of the test drug, except simple appendectomy and hernia surgery)
3. Participants with hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs including sorafenib and allogeneic drugs, and other drugs (aspirin, antibiotics, etc.)