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

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.

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.