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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004993-16 | EudraCT Number |
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The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the autoinjector and pre-filled syringe of SB4 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | SB4 (etanercept) 50 mg/mL PFS and AI |
|
| Sequence 2 | Experimental | SB4 (etanercept) 50 mg/mL AI and PFS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | 50 mg/mL PFS and AI |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf ACUinf | Area under the concentration-time curve from time zero to infinity | 56 days |
| AUClast | Area under the concentration-time curve from time zero to the last quantifiable concentration | 56 days |
| Cmax | Maximum serum concentration | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | Netherlands |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| 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 |