Study With Heparin Sodium in Subcutaneous Administration

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heparin

Intervention / Treatment
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* Biological: Sodium Heparin UQ subcutaneous drug administration
* Biological: Sodium Heparin FK subcutaneous drug administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Hospitalizations for administration of study medications will occur in two periods (visits 1 and 2) for administration of the drugs, and participants who receive the test medication at visit 1 will receive the comparator medication at Visit 2 and vice versa.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Sodium Heparin UQ First<br>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<br>* 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<br>Biological: Sodium Heparin FK subcutaneous drug administration<br>* 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<br>|
| Experimental: Group Sodium Heparin FK First<br>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<br>* 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<br>Biological: Sodium Heparin FK subcutaneous drug administration<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity of the anti-Xa factor | Chromogenic determination of direct and indirect inhibitors in human citrated plasma | 8 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sodium Heparin, Pharmacokinetics, Coagulation factor