Heparin Clinical Trial
Official title:
Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Subcutaneous Use in Healthy Participants
The purpose of this phase I study is to know the pharmacodynamic profile in humans of the sodium heparin of porcine origin of the company União Química, building from the pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of heparin directly in biological samples. In addition, the toxicity of the product will be evaluated in healthy male participants.
This stage of product development follows the guidelines of the ANVISA (National Health
Surveillance Agency) Heparin Development Guide.
Unfractionated sodium heparin is a drug known and widely used in the world for over half a
century, thus, no unknown adverse events or any risk of administration are expected in
humans, however, this is the first human Biological product developed by União Química. The
proposed development of this biological drug follows the individual route, the control
heparin used in the present study has the objective of evaluating the results found with the
test product, without the obligation to demonstrate bioequivalence among the evaluated
products.
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