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| ID | Type | Description | Link |
|---|---|---|---|
| VERSION 3 |
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The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN Comparator: Rebif ® - Merck Serono Lab) after single administration (12.000UI) in healthy subjects by modifying the parameters Cmax, Tmax and AUC (pharmacokinetics) and the levels of 2'5' oligoadenylate synthase and beta-2-microglobulin (pharmacodynamics).
Secondly, safety will be observed (tolerability) clinically after administration of a single dose in study subjects, by comparing the clinical and laboratory parameters before and after study and the incidence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Bergamo - Interferon beta-1a |
|
| Comparator - Merck Serono | Active Comparator | Merck Serono - Interferon beta-1a |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1a | Biological | 12.000UI - single dose |
| |
| Interferon beta-1a |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a. | Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification | 168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Security: observation of adverse effects | 168 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lal Clinica Pesquisa E Desenvolvimento Ltda | Valinhos | São Paulo | 13270000 | Brazil |
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| Biological |
12.000UI - Single dose |
|
| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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