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

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ClinicalTrials.gov Identifier: NCT01692158
Recruitment Status : Unknown
Verified September 2012 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
First Posted : September 25, 2012
Last Update Posted : September 25, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Heparin, Low-Molecular-Weight Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Teste
Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.
Drug: Heparin, Low-Molecular-Weight
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.
Other Names:
  • Clexane
  • Enoxalow
Active Comparator: Comparador
Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis
Drug: Heparin, Low-Molecular-Weight
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.
Other Names:
  • Clexane
  • Enoxalow


Outcome Measures

Primary Outcome Measures :
  1. anti-FXa [ Time Frame: 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 ]
  2. anti-FIIa activity [ Time Frame: 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 Outcome Measures :
  1. Tissue Factor Pathway Inhibitor (TFPI) [ Time Frame: 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 ]
  2. ratio of anti-FXa and anti-FIIa activity [ Time Frame: 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692158


Contacts
Contact: Alexandre Frederico +55 19 3871-6399 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clinica Not yet recruiting
Valinhos, Sao Paulo, Brazil, 13276-245
Contact: Alexandre Frederico    +55 19 38716399    alexandre@lalclinica.com.br   
Contact: Simone Castro    +55 19 38716399    simone.castro@lalclinica.com.br   
Principal Investigator: Alexandre Frederico         
Sponsors and Collaborators
Azidus Brasil
Investigators
Principal Investigator: Alexandre Frederico Azidus Brasil
More Information

Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT01692158     History of Changes
Other Study ID Numbers: ENOBLA0512SC-I
Versão 01 datada de 15.05.2012 ( Other Identifier: LAL Clinica )
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by Azidus Brasil:
subjects

Additional relevant MeSH terms:
Calcium heparin
Heparin
Enoxaparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action