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| Name | Class |
|---|---|
| Chungnam National University Hospital | OTHER |
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The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg) when administered a single-dose to healthy male volunteers.
Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYP-1512 Tab and Revlimid cap (25mg) as of lenalidomide 25mg.
Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYP-1512 Tab and Revlimid cap (25mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYP-1512 | Experimental | Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I&II D1(crossover) |
|
| Revlimid cap. | Active Comparator | Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I&II D1(crossover) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYP-1512 | Drug | Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I&II D1(crossover) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of the AUCt between SYP-1512 and Revlimid cap(25mg) | Bioequivalance of the AUCt between SYP-1512 and Revlimid cap(25mg) | 0-24hours |
| Pharmacokinetics of the Cmax between SYP-1512 and Revlimid cap(25mg) | Bioequivalance of the Cmax between SYP-1512 and Revlimid cap(25mg) | 0-24hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of the AUCinf SYP-1512 and Revlimid cap (25mg) | Bioequivalance of the AUCinf SYP-1512 and Revlimid cap (25mg) | 0-inf |
| Pharmacokinetics of the Tmax of SYP-1512 and Revlimid cap (25mg) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Revlimid cap | Drug | Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I&II D1(crossover) |
|
|
Bioequivalance of the Tmax of SYP-1512 and Revlimid cap (25mg)
| 0-24hours |
| Pharmacokinetics of the T1/2 of SYP-1512 and Revlimid cap (25mg) | Bioequivalance of the T1/2 of SYP-1512 and Revlimid cap (25mg) | 0-24hours |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |