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| ID | Type | Description | Link |
|---|---|---|---|
| VersĂŁo 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 | Other | First periody: Heparin Test Drug (Blau FarmacĂȘutica S/A) Secundy periody: Heparin Comparator Drug (APP Pharmaceuticals) |
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| Group B | Other | First periody: Heparin Comparator Drug (APP Pharmaceuticals) Secundy periody: Heperin Test Drug (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 intravenously. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA | Blood samples | 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 and TTPa | Blood samples | 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. TTPa: 0:20, 0:10 before administration and 1 h, 4h, 8h, 12h and 24h after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
a) Participation in clinical trials in the 12 months preceding the survey; b) Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems; c) acute illness in the period up to 07 days before the beginning of the study; d) determining Chronic administration of medications, such as hypertension, diabetes or any other that requires continued use of any drug; e) Hemoglobin <13 g / dL; f) Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory; g) Use of medications that interact with heparin (see Section 7.8.1); h) history of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism; i) History of coagulopathy and bleeding diathesis; j) Presence of bruises on physical examination. k) Changes in skin or subcutaneous tissue of the place where the injection is made (eg liposuction in the abdomen).
l) absolute platelet count below 100 x 109 / L; m) A history of acute haemorrhage in the last 30 days; n) history of sensitivity to biological products derived from mammalian albumin or any component of the formulation;
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, physian | 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 | SĂŁo Paulo | 13276245 | Brazil |
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|
| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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