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| ID | Type | Description | Link |
|---|---|---|---|
| PK-CIA-06 |
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The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced anemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monofer 500 mg | Active Comparator |
| |
| Monofer 250 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monofer(R) | Drug | Intravenous bolus injection given over app. 2 minutes only once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total serum iron pharmacokinetic parameters: AUC0-t, AUC Cmax, Tmax, Ke, and T1/2 estimated from plasma/serum concentration profile from exposure to 7 days post-exposure. | 0-7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore, MD | Maryland | 21237 | United States | |||
| Gabrail Cancer Center |
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| Canton |
| Ohio |
| United States |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
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