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| ID | Type | Description | Link |
|---|---|---|---|
| PK-IBD-02 |
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The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1000 mg iron isomaltoside as intravenous infusion | Active Comparator |
| |
| 500 mg iron isomaltoside 1000 as bolus injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monofer (iron isomaltoside 1000) | Drug | 1000 mg iron isomaltoside administered as a infusion over 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total serum iron pharmakokinetic parameters | 24, 48 and72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total urine-iron pharmakokinetic parameters | 24, 48 and 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Lykke Thomsen, MD | Pharmacosmos A/S | Study Chair |
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| Monofer | Drug | 500 mg iron isomaltoside 1000 given as bolus injection over 2 minutes |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
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