Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose
- Conditions
- Healthy
- Interventions
- Drug: Heparin, Low-Molecular-Weight
- Registration Number
- NCT01692158
- Lead Sponsor
- Azidus Brasil
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Comparador Heparin, Low-Molecular-Weight Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis Teste Heparin, Low-Molecular-Weight Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.
- Primary Outcome Measures
Name Time Method anti-FIIa activity 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration anti-FXa 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration
- Secondary Outcome Measures
Name Time Method Tissue Factor Pathway Inhibitor (TFPI) 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration ratio of anti-FXa and anti-FIIa activity 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration
Trial Locations
- Locations (1)
LAL Clinica
🇧🇷Valinhos, Sao Paulo, Brazil