PHARMACODYNAMICS ASSESSMENT PRODUCT HEPARIN SODIUM (SUBCUTANEOUSLY) OF THE SWINE 5.000UI/ML OF BLAU FARMACÊUTICA S/A IN HEALTHY SUBJECTS IN COMPARISON OF SODIUM HEPARIN APP PHARMACEUTICALS

Study Overview
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Brief Summary
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The objective of this clinical, randomized, crossover, is to assess the pharmacodynamic profile of the drug Heparin Sodium from swine (intravenously), manufactured and marketed by Laboratory Blau Farmacêutica S/A, compared to the product of Heparin Sodium ® company APP Pharmaceuticals, through the determination of activity of the following markers: Anti-FXa; Anti-FIIA.

Detailed Description
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The pharmacodynamic profile of the drug will be assessed through: Reason for Anti-FXa activity / Anti-FIIA; TFPI activity. The aPTT activity marker will be evaluated as an exploratory objective.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirm the voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways; Being male, aged between 18 and 55 years old and clinically healthy; BMI ≥ 18.5 and ≤ 30. Exclusion Criteria: Participation in clinical trials in the 12 months preceding the survey; Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems; acute illness in the period up to 07 days before the beginning of the study; determining Chronic administration of medications, such as hypertension, diabetes or any other that requires continued use of any drug; Hemoglobin <13 g / dL; Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory; Use of medications that interact with heparin (see Section 7.8.1); history of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism; History of coagulopathy and bleeding diathesis; Presence of bruises on physical examination. Changes in skin or subcutaneous tissue of the place where the injection is made (eg liposuction in the abdomen). absolute platelet count below 100 x 109 / L; A history of acute haemorrhage in the last 30 days; history of sensitivity to biological products derived from mammalian albumin or any component of the formulation; a) history of allergy or major disease Steven Johnson; p) History of present use or there are at least 12 months of tobacco; q) current or previous history (less than 12 months) of illicit drug use;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>First periody: Test Drug (Heparin Blau Farmacêutica S/A) Secundy periody: Comparator Drug (Heparin APP Pharmaceuticals) | Drug: Heparin<br>* Whereas it will be a crossover study with two periods, each drug will be administered only once, at a dose of 5.000UI. In each period, the drug will be administered subcutaneously.<br>* Other names: APP Sodium heparin = Sodium heparin (App Pharmaceuticals);|
| Experimental: Group B<br>First periody: Comparator Drug (Heparin APP Pharmaceuticals) Secundy periody: Test Drug (heparin Blau Farmacêutica S/A) | Drug: Heparin<br>* Whereas it will be a crossover study with two periods, each drug will be administered only once, at a dose of 5.000UI. In each period, the drug will be administered subcutaneously.<br>* Other names: APP Sodium heparin = Sodium heparin (App Pharmaceuticals);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic of activity of markers: Anti-Fxa and Anti-FIIA. | Blood sample | 0:20, 0:10 before administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30 , 5, 6, 8, 12 and 24 hours after drug administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic of the ratio between the activity Anti-FXa/Anti-FIIa and the activity of TFPI. | Blood sample | TFPI: 0:20, 0:10 before administration and 0:10, 0:20, 0:30, 0:45, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30 , 5, 6, 8, 12 and 24 hours after drug administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subjects