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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002866-29 | EudraCT Number |
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The study consists of generation of biological samples (in blood and urine) positive to Epoetin alfa for laboratories that wish to perform the analysis of doping controls and maintain accreditation from World Anti-Doping Agency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPOETIN ALFA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPOETIN ALFA | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood and urine concentrations of Epoetin alfa | Urine samples will be collected in different time periods: -48 to -24h, - 24h to 0h (pre-administration), 0 to 24h, 24 to 48h, 48 to 72h, 72 to 96h, 96 to 120h and 120 to 144h (post-administration). 10 mL of blood and dried blood spot (DBS) microvolume sampling with FTA DMPK -C cards will be collected at different time points: 48-72 hours before the first administration of the drug, before administration (0h, baseline), at 24, 48, 72 and 96 hours after administration of the drug. In session 5, blood samples will be collected at 0h (pre-administration) and at 1h, 4h and 8h after the administration of the drug. | From 48-72 hours pre-administration to 144 hours post administration |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |