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This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegfilgrastim Megalabs | Experimental | Pegfilgrastim injectable 6 mg in a single subcutaneous application. |
|
| Pegfilgastrim Neulastim | Active Comparator | Neulastim injectable 6 mg in a single subcutaneous application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegfilgastrim Megalabs | Biological | Administration of 6 mg of Pegfilgrastim Megalabs subcutaneous single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Cmax in healthy volunteers for test and reference | 16 days | |
| Evaluation of AUC 0-t of pegfilgrastim in healthy volunteers for test and reference | 16 days | |
| Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference | 16 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of CD34+ count for test and reference | 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Pedrazzoli Junior, MD | Unidade Integrada de Farmacologia e Gastroenterologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marcos Giusti | Montevideo | 11300 | Uruguay |
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| ID | Term |
|---|---|
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| Pegfilgastim Amgen | Biological | Administration of 6 mg of Pegfilgrastim Amgen subcutaneous single dose |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |