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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-8989 | Other Identifier | WHO | |
| 101192 | Registry Identifier | JAPIC |
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This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects. In addition pharmacokinetic parameters will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
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| B | Experimental |
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| C | Placebo Comparator |
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| D | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catridecacog | Drug | Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute. |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of serious adverse events | from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing | |
| Occurrence of non-serious adverse events | from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (area under the curve) from time zero to 28 days | at day 28 |
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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 |
|---|---|---|---|---|---|---|
| Fukuoka | 812-0025 | Japan |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Single rFXIII placebo dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute. |
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| catridecacog | Drug | Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute. |
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| placebo | Drug | Single rFXIII placebo dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute. |
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