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

Launched by AZIDUS BRASIL · Sep 24, 2012

Keywords

ClinConnect Summary

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.

Gender

MALE

Eligibility criteria

• 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.