NCT01651923

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Heparin	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.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-07-27
• Last updated: 2012-08-13

Locations

1 site across 1 country: Brazil