Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose

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

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 subcutaneous 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.

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 secondary objectives.

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);
• Changes in the skin or subcutaneous tissue of the place of drug administration(eg liposuction in the abdomen);
• 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.