Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Intravenous Administration

Study Overview
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Brief Summary
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The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following administration of single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa), as surrogate markers for their circulating concentrations of the drug.

Detailed Description
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In addition other pharmacodynamic tests such as Tissue Factor Pathway Inhibitor (TFPI) activity, as well as the ratio of anti-FXa and anti-FIIa activity will be compared as secundary obectives.

Official Title
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Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Intravenous Administration.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Heparin, Low-Molecular-Weight


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agree to all the purposes of the study by signing and dating the Informed Consent; Male, aged between 18 and 55 years, clinically healthy; BMI between 18.5 and 30; Exclusion Criteria: Participation in clinical trials in the 12 months preceding the trial; Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases; Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study; Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug; Hemoglobin <13 g/dL; Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory drugs; Use of medications that interact with enoxaparin; History of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism that may interfere with the clinical outcome of the study; History of coagulopathy and bleeding diathesis; Presence of changes in physical examination suggestive of coagulation disorders (bruising, petechiae, or bruising); Body weight < 45 kg or > 100 kg; Absolute platelet count below 100 x 109 / L; History of chronic bleeding; History of acute haemorrhage in the past 30 days; History of sensitivity to mammalian-derived biological products, albumin or any component of the formulation; History of allergy or Steven Johnson disease; Current or previous history (under 12 months) use of illicit drugs and tobacco; History of alcohol abuse, current or previous (within 12 months); At the discretion of the Principal Investigator of the study.

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: Teste<br>Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A. | Drug: Heparin, Low-Molecular-Weight<br>* single intravenous administration of 3mg/Kg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.<br>* Other names: Enoxalow;|
| Active Comparator: Comparador<br>Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis | Drug: Heparin, Low-Molecular-Weight<br>* single intravenous administration of 3mg/Kg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.<br>* Other names: Enoxalow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the pharmacodynamic profile of the drug test in comparison to the comparator through the measurement of the activity of the Anti-FXa and anti-FIIa markers | Post drug administration blood samples were collected at following times - 0; 0:10; 0:20; 0:30; 00:40 12:50; 1; 1:30; two; 2:30; 3; 3:30; 4; 5; 6; 8; 10; 12; 16:24 (± 30) hours after. | The day after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the pharmacodynamic profile of the drug test in comparison to the comparator through the measurement of the activity of the TFPI marker and ratio of Anti-FXa and anti-FIIa. | Post drug administration blood samples were collected at following times - 0; 0:10; 0:20; 0:30; 00:40 12:50; 1; 1:30; two; 2:30; 3; 3:30; 4; 5; 6; 8; 10; 12; 16:24 (± 30) hours after. | The day after admission | 

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