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To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator, Enbrel® 25mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Enbrel, LBEC0101 |
|
| Group 2 | Experimental | LBEC0101, Enbrel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBEC0101 (Etanercept 25mg) | Drug |
| ||
| Enbrel (Etanercept 25mg) |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, M.D., Ph.D. | Seoul National University College of Medicine and Hospitaal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital, Clinical Trial Center | Seoul | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28551775 | Derived | Lee H, Chung H, Lee S, Lee H, Yang SM, Yoon SH, Cho JY, Jang IJ, Yu KS. LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects. BioDrugs. 2017 Aug;31(4):349-355. doi: 10.1007/s40259-017-0230-9. |
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| ID | Term |
|---|---|
| C000626868 | LBEC0101 |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Drug |
|
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |