Study With Heparin Sodium in Subcutaneous Administration

Phase 1

Suspended

• Conditions: Heparin
• Interventions: Biological: Sodium Heparin UQ subcutaneous drug administration; Biological: Sodium Heparin FK subcutaneous drug administration

• Registration Number: NCT03113084
• Lead Sponsor: União Química Farmacêutica Nacional S/A

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Status Verified: 2019-06
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-14
• Study Start: 2022-08-20
• Primary Completion: 2023-04-20
• Study Completion: 2023-10-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 38

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group Sodium Heparin FK First	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
Group Sodium Heparin UQ First	Sodium Heparin UQ subcutaneous drug administration	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
Group Sodium Heparin FK First	Sodium Heparin UQ 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
Group Sodium Heparin UQ First	Sodium Heparin FK subcutaneous drug administration	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

Primary Outcome Measures

Name	Time	Method
Activity of the anti-Xa factor	8 hours	Chromogenic determination of direct and indirect inhibitors in human citrated plasma

Secondary Outcome Measures

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

Trial Locations

Locations (1)

União Química Farmacêutica Nacional; 🇧🇷 São Paulo, Brazil