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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
The participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication. They will receive the intravenous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
The participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication. They will receive the intravenous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
União Química Farmacêutica Nacional
São Paulo, Brazil
activity of the anti-Xa factor
Chromogenic determination of direct and indirect Xa inhibitors in human citrated plasma
Time frame: 8 hours
Activity of anti-IIa factors,
Chromogenic determination of activity of anti-IIa factor
Time frame: 8 hours
ratio of activity of anti-Xa / anti-IIa
activity of anti-Xa / anti-IIa ratio
Time frame: 8 hours
Activity of tissue factor pathway activity (TFPI)
Elisa assay to measure the activity of tissue factor pathway activity (TFPI)
Time frame: 8 hours
adverse events.
Adverse events occurred in the study
Time frame: 45 days
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