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PHARMACODYNAMICS ASSESSMENT PRODUCT HEPARIN SODIUM (INTRAVENOUSLY) OF THE SWINE 5.000UI/ML OF BLAU FARMACÊUTICA S/A IN HEALTHY SUBJECTS IN COMPARISON OF SODIUM HEPARIN APP PHARMACEUTICALS

Healthy Clinical Trial

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01651923
Study type Interventional
Source L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Contact Alexandre Frederico, physian
Phone + 55 19 3871-6399
Email alexandre@lalclinica.com.br
Status Not yet recruiting
Phase Phase 1
Start date February 2013
Completion date April 2013
View Details
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