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Study With Heparin Sodium in Intravenous Administration

Heparin Clinical Trial

Official title:
Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Intravenous Use in Healthy Participants

Clinical Trial Summary

The purpose of this phase I study is to know the pharmacodynamic profile in in intravenous application 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03125187
Study type Interventional
Source União Química Farmacêutica Nacional S/A
Contact
Status Suspended
Phase Phase 1
Start date February 20, 2021
Completion date November 10, 2022
View Details
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