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

Samyang Biopharmaceuticals Corporation

Status and phase: Completed; Phase 1

Conditions: Healthy, Male

Treatments: Drug: Nexavar tab; Drug: SYO-1644

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03674060

SYO-1644

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

SYO-1644 100mg

Experimental group

Description:

SYO-1644 tablet, PO, 1 100mg tablet

Treatment:

Drug: SYO-1644

SYO-1644 150mg

Experimental group

Description:

SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet

Treatment:

Drug: SYO-1644

SYO-1644 200mg

Experimental group

Description:

SYO-1644 tablet, PO, 2 100mg tablet

Treatment:

Drug: SYO-1644

Nexavar

Active Comparator group

Description:

Nexavar 200mg/tablet, PO, 1 tablet

Treatment:

Drug: Nexavar tab