Healthy
Conditions
Keywords
subjects
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.
Interventions
single subcutaneuous administration of 40 mg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed