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| ID | Type | Description | Link |
|---|---|---|---|
| Version 01 15/03/2012 |
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The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by Laboratory Blau FarmacĂȘutica S/A, compared to the product of Heparin Sodium Âź company APP Pharmaceuticals, through the determination of activity of the following markers:
The pharmacodynamic profile of the drug will be assessed through:
The aPTT activity marker will be evaluated as an exploratory objective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | First periody: Test Drug (Heparin Blau FarmacĂȘutica S/A) Secundy periody: Comparator Drug (Heparin APP Pharmaceuticals) |
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| Group B | Experimental | First periody: Comparator Drug (Heparin APP Pharmaceuticals) Secundy periody: Test Drug (heparin Blau FarmacĂȘutica S/A) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin | Drug | Whereas it will be a crossover study with two periods, each drug will be administered only once, at a dose of 5.000UI. In each period, the drug will be administered subcutaneously. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA. | Blood sample | 0:20, 0:10 before administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30 , 5, 6, 8, 12 and 24 hours after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic of the ratio between the activity Anti-FXa/Anti-FIIa and the activity of TFPI. | Blood sample | TFPI: 0:20, 0:10 before administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30 , 5, 6, 8, 12 and 24 hours after drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
a) history of allergy or major disease Steven Johnson; p) History of present use or there are at least 12 months of tobacco; q) current or previous history (less than 12 months) of illicit drug use;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Frederico, physician | Contact | +55 19 3871-6399 | alexandre@lalclinica.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL ClĂnica Pesquisa e Desenvolvimento Ltda. | Valinhos | Valinhos | 13276245 | Brazil |
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|
| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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