Clinical trial NCT01692158: Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: subjects
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: anti-FXa
timeFrame: 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
measure: anti-FIIa activity
timeFrame: 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 outcomes:
measure: Tissue Factor Pathway Inhibitor (TFPI)
timeFrame: 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
measure: ratio of anti-FXa and anti-FIIa activity
timeFrame: 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
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica
state: Sao Paulo
Study officials:
affiliation: Azidus Brasil
name: Alexandre Frederico
role: PRINCIPAL_INVESTIGATOR
References: