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This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] Syringe | Drug | Single dose administration with pre-filled syringe |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra | 21 days | |
| Peak plasma concentration of RoActemra/Actemra | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Incidence of adverse events) | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier | 34094 | France | ||||
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| tocilizumab [RoActemra/Actemra] auto-injector |
| Drug |
Single dose administration with auto-injector |
|
| Rennes |
| 35042 |
| France |
| ID | Term |
|---|---|
| C502936 | tocilizumab |
| D013594 | Syringes |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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