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The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Z-213 100mg | Experimental | Group/Cohort Label: 100 mg iron Z-213 will be administered by intravenous infusion. |
|
| Z-213 500mg | Experimental | Group/Cohort Label: 500 mg iron Z-213 will be administered by intravenous infusion. |
|
| Z-213 800mg | Experimental | Group/Cohort Label: 800 mg iron Z-213 will be administered by intravenous infusion. |
|
| Z-213 1000mg | Experimental | Group/Cohort Label: 1000 mg iron Z-213 will be administered by intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z-213 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of total serum iron (Cmax), (Tmax), (AUC0-t), (AUC0-24),(AUC0-72),(T1/2), (CL), (Vd, area), (Vd, ss), (MRT) or total urine iron (CLren), (Ae). | 8days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeria Investigator | Zeria Pharmaceutical Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeria Investigative Site | Tokyo | Japan |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |