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Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator, Intravenous Administration

Anticoagulant Clinical Trial

Official title:
Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacodynamics of an Unfractionated Heparin Compared to Heparin Sodium Injection, USP (Comparator) After Intravenous Administration in Healthy Subjects

Clinical Trial Summary

Pharmacodynamic Study - Phase I Experimental Drug: Porcine sodium heparin, injectable solution - 5,000 IU/mL; Blau Farmacêutica S/A. Comparator Drug: Heparin Sodium Injection, USP, injectable solution - 5,000 IU/mL; Fresenius Kabi Lake Zurich. Evaluate the equivalence in terms of pharmacodynamics of heparin sodium (test product) and Heparin Sodium Injection, USP (comparator product). The clinical trial will last approximately 08 weeks and the study population will consist of 68 healthy research participants, 34 women and 34 men.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05788900
Study type Interventional
Source Blau Farmaceutica S.A.
Contact Blau Farmacêutica
Phone 114615-9400
Email pesquisaclinica@blau.com
Status Not yet recruiting
Phase Phase 1
Start date June 1, 2023
Completion date September 30, 2023
View Details
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