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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYO-1644 100mg | Experimental | SYO-1644 tablet, PO, 1 100mg tablet |
|
| SYO-1644 150mg | Experimental | SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet |
|
| SYO-1644 200mg | Experimental | SYO-1644 tablet, PO, 2 100mg tablet |
|
| Nexavar | Active Comparator | Nexavar 200mg/tablet, PO, 1 tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYO-1644 | Drug | 100mg: SYO-1644 tablet, PO, 1 100mg tablet 150mg: SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet 200mg: SYO-1644 tablet, PO, 2 100mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pharmacokinetic properties | Pharmacokinetics of the AUCt between SYO-1644 and Nexavar cap(200mg) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours |
| Evaluation of pharmacokinetic properties | Pharmacokinetics of the Cmax between SYO-1644 and Nexavar cap(200mg) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours |
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Inclusion Criteria:
Healthy male age between 19 and 50 years old at the time of screening
Healthy male more than or equal to 50 kg or less than or equal to 90 kg with BMI of 18~27
Agreement with written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Nexavar tab | Drug | Nexavar 200mg/tablet, PO, 1 tablet |
|
|
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |