Study With Heparin Sodium in Subcutaneous Administration

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03113084
• Other study ID #: PGUQ003
• Status: Suspended
• Phase: Phase 1
• Start date: August 20, 2022
• Est. completion date: October 10, 2023

Study information

• Verified date: June 2019
• Source: União Química Farmacêutica Nacional S/A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 38
• Est. completion date: October 10, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Eligible healthy participants should sign the Informed Consent Form,

• be between 18 and 60 years of age,

• be male,

• present a BMI = 18.5 and = 29.9 kg / m2,

• be characterized as a voluntary (Normal physical examination)

• no history of current or recent diseases.

Exclusion criteria:

• hemoglobin <12 g / dL;

• Platelets <100 x 109 / L;

• Regular or last 30 days use of anticoagulant medications;

• Current or past use of anti-inflammatory or anti-platelet medications;

• History of gastrointestinal bleeding;

• History of venous thrombosis, pulmonary embolism, coagulopathies or any coagulation disorder;

• Any other chronic illness or regular use of drugs that at the discretion of the investigator contraindicates participation in the study,

• serious comorbidity (at the discretion of the researcher) of any nature that could compromise participation in the study or put the participant at risk considered to be unacceptable,

• Laboratory that at the discretion of the investigator contraindicates the participation of the participant in the study;

• Hypersensitivity or contraindication to the components of the medications studied, participation in another clinical study in less than 1 year (unless justified by the investigator)

• donation of blood (> 500 mL) in the preceding 3 months.

Related Conditions & MeSH terms

• Heparin

Intervention

Biological:
• Sodium Heparin UQ 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
• Sodium Heparin FK subcutaneous drug administration
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

Locations

Country	Name	City	State
Brazil	União Química Farmacêutica Nacional	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
União Química Farmacêutica Nacional S/A	Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity of the anti-Xa factor	Chromogenic determination of direct and indirect inhibitors in human citrated plasma	8 hours
Secondary	Activity of anti-IIa factor	Chromogenic determination of direct and indirect inhibitors in human citrated plasma	8 hours
Secondary	activity of anti-Xa / anti-IIa ratio	the calculated ratio of the activity of anti-Xa / anti-IIa	8 hours
Secondary	activity of tissue factor pathway activity (TFPI)	the Elisa assay will determine the activity of tissue factor pathway activity (TFPI)	8 hours
Secondary	adverse events	Adverse events occurred in the study	45 days