Clinical trial NCT01692171: Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Intravenous Administration
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 Intravenous Administration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Subjects
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: Blau Farmaceutica S.A.
First posted: 2012-09-25
Enrollment: 32
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 intravenous 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 secundary obectives.

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);
* Body weight \< 45 kg or \> 100 kg;
* 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: Assess the pharmacodynamic profile of the drug test in comparison to the comparator through the measurement of the activity of the Anti-FXa and anti-FIIa markers
timeFrame: The day after admission
Secondary outcomes:
measure: Assess the pharmacodynamic profile of the drug test in comparison to the comparator through the measurement of the activity of the TFPI marker and ratio of Anti-FXa and anti-FIIa.
timeFrame: The day after admission
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica
state: Sao Paulo
Study officials:
affiliation: Blau Farmaceutica S.A.
name: Márcia Guidone, manager
role: STUDY_DIRECTOR
References:
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citation: Hirsh J, Warkentin TE, Shaughnessy SG, Anand SS, Halperin JL, Raschke R, Granger C, Ohman EM, Dalen JE. Heparin and low-molecular-weight heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest. 2001 Jan;119(1 Suppl):64S-94S. doi: 10.1378/chest.119.1_suppl.64s. No abstract available.
citation: Kuczka K, Harder S, Picard-Willems B, Warnke A, Donath F, Bianchini P, Parma B, Blume H. Biomarkers and coagulation tests for assessing the biosimilarity of a generic low-molecular-weight heparin: results of a study in healthy subjects with enoxaparin. J Clin Pharmacol. 2008 Oct;48(10):1189-96. doi: 10.1177/0091270008322911. Epub 2008 Aug 20.
citation: Mousa SA, Bozarth J, Barrett JS. Pharmacodynamic properties of the low molecular weight heparin, tinzaparin: effect of molecular weight distribution on plasma tissue factor pathway inhibitor in healthy human subjects. J Clin Pharmacol. 2003 Jul;43(7):727-34.
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