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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002190-63 | EudraCT Number |
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The purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of iron in blood) after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate) in women with iron deficiency anaemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tardyferon 80 mg | Drug | Oral administration (2 tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement | Pharmacokinetic profile of serum iron after single oral administration of ferrous sulphate supplement by measuring Maximum Plasma concentration, Time of Maximum Concentration, Area under the iron plasma concentration curve. | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of single administration (reported adverse events) | Tolerability by evaluating the number of subjects with emergent adverse events | Up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iași | Romania | |||||
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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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| ID | Term |
|---|---|
| C009380 | ferrous sulfate, mucin drug combination |
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| Timișoara |
| 300244 |
| Romania |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |