A Phase 1 interventional study of Heparin in Healthy, sponsored by Azidus Brasil. Status unknown at 1 site in Brazil. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-13.
Sponsored by Azidus Brasil · Phase 1, Interventional, and Treatment
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:
The pharmacodynamic profile of the drug will be assessed through:
The aPTT activity marker will be evaluated as an exploratory objective.
Azidus Brasil is the lead sponsor of 78 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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;
First periody: Test Drug (Heparin Blau Farmacêutica S/A) Secundy periody: Comparator Drug (Heparin APP Pharmaceuticals)
Drug: Heparin
First periody: Comparator Drug (Heparin APP Pharmaceuticals) Secundy periody: Test Drug (heparin Blau Farmacêutica S/A)
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 subcutaneously.
Also known as: Hepamax-S = Sodium heparin (Blau Farmacêutica S/A), APP Sodium heparin = Sodium heparin (App Pharmaceuticals)
Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA.
Blood sample
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.
Blood sample
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.
This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Azidus Brasil