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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016438-28 | EudraCT Number | ||
| U1111-1113-2008 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial part 1 | Experimental |
| |
| Trial part 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catridecacog | Drug | Single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) administered iv. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay | after 4 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (serious and non-serious) | over 8 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Harrow | HA1 3UJ | United Kingdom |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| recombinant factor XIII | Drug | Single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) to be administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv. |
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| ID | Term |
|---|---|
| C521905 | recombinant factor XIII-A2 |
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