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 Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP Pharmaceuticals, through the determination of activity of the following markers: * Anti-FXa; * Anti-FIIA.
The pharmacodynamic profile of the drug will be assessed through: * Reason for Anti-FXa activity / Anti-FIIA; * TFPI activity. The aPTT activity marker will be evaluated as an exploratory objective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
LAL Clínica Pesquisa e Desenvolvimento Ltda.
Valinhos, São Paulo, Brazil
Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA
Blood samples
Time frame: 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.
Pharmacodynamic of the ratio between the activity Anti-FXa/Anti-FIIa and the activity of TFPI and TTPa
Blood samples
Time frame: 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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