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| ID | Type | Description | Link |
|---|---|---|---|
| Versão 01 datada de 15.05.2012 | Other Identifier | LAL Clinica |
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The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following administration of single subcutaneous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa), as surrogate markers for their circulating concentrations of the drug.
In addition other pharmacodynamic tests such as Tissue Factor Pathway Inhibitor (TFPI) activity, as well as the ratio of anti-FXa and anti-FIIa activity will be compared as secondary objectives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teste | Experimental | Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A. |
|
| Comparador | Active Comparator | Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin, Low-Molecular-Weight | Drug | single subcutaneuous administration of 40 mg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout. |
| Measure | Description | Time Frame |
|---|---|---|
| anti-FXa | 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration | |
| anti-FIIa activity | 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Factor Pathway Inhibitor (TFPI) | 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration | |
| ratio of anti-FXa and anti-FIIa activity | 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Frederico | Azidus Brasil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL Clinica | Valinhos | São Paulo | 13276-245 | Brazil |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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