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 |
|---|---|
| Severance Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYO-1126 and Glivec Film Coated tab 4T (400mg) when administered a single-dose to healthy male volunteers.
Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYO-1126 and Glivec Film Coated tab 4T (400mg) as of imatinib 400mg.
Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYO-1126 and Glivec Film Coated tab 4T (400mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYO-1126 | Experimental | Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover) |
|
| Glivec film coated tab 4T(400mg) | Active Comparator | 100mg/tablet, po, 4 tablets once daily for period I&II D1(crossover) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYO-1126 | Drug | Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg) | 0-72hr | |
| Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg) | 0-72hr |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of the AUCinf SYO-1126 and Glivec Film Coated 4T(400mg) | 0-72hr | |
| Evaluation of the safety of SYO-1126 and Glivec Film Coated 4T(400mg) from vital signs, physical exam, ECG, laboratory test, adverse events and so on. | 20~24 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Min Su Park, Doctor | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Seoul | Seodaemun-gu | South Korea |
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Glivec film coated tab 4T(400mg) | Drug | Imatinib 100mg/tablet, PO, 4 tablets once daily for period I&II D1(crossover) |
|
|
| Pharmacokinetics of the Tmax of SYO-1126 and Glivec Film Coated 4T(400mg) | 0-72hr |
| Pharmacokinetics of the T1/2 of SYO-1126 and Glivec Film Coated 4T(400mg) | 0-72hr |
| Pharmacokinetics of the CL/F of SYO-1126 and Glivec Film Coated 4T(400mg) | 0-72hr |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |