A Phase 1 interventional study of Sodium Heparin UQ subcutaneous drug administration and Sodium Heparin FK subcutaneous drug administration in Heparin, sponsored by União Química Farmacêutica Nacional S/A. Suspended at 1 site in Brazil. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-14.
Sponsored by União Química Farmacêutica Nacional S/A · Phase 1, Interventional, and Other
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.
União Química Farmacêutica Nacional S/A is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The participants will receive the Sodium heparin UQ subcutaneous drug administration at first period and the Sodium heparin FK subcutaneous drug administration at second period
Biological: Sodium Heparin UQ subcutaneous drug administration · Biological: Sodium Heparin FK subcutaneous drug administration
The participants will receive the Sodium heparin FK subcutaneous drug administration at first period and the Sodium heparin UQ subcutaneous drug administration at second period
Biological: Sodium Heparin UQ subcutaneous drug administration · Biological: Sodium Heparin FK subcutaneous drug administration
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 Subcutaneous 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 subcutaneous 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
Activity of the anti-Xa factor
Chromogenic determination of direct and indirect inhibitors in human citrated plasma
Time frame: 8 hours
Activity of anti-IIa factor
Chromogenic determination of direct and indirect inhibitors in human citrated plasma
Time frame: 8 hours
activity of anti-Xa / anti-IIa ratio
the calculated ratio of the activity of anti-Xa / anti-IIa
Time frame: 8 hours
activity of tissue factor pathway activity (TFPI)
the Elisa assay will determine the activity of tissue factor pathway activity (TFPI)
Time frame: 8 hours
adverse events
Adverse events occurred in the study
Time frame: 45 days
Plan to share: No
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This study is suspended, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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União Química Farmacêutica Nacional S/A