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

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.

Timeline

Start

2023-06-01

Primary completion

2023-06-30

Completion

2023-09-30

Drugs

Indications

No indication recorded.