<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01692158</url>
  </required_header>
  <id_info>
    <org_study_id>ENOBLA0512SC-I</org_study_id>
    <secondary_id>Versão 01 datada de 15.05.2012</secondary_id>
    <nct_id>NCT01692158</nct_id>
  </id_info>
  <brief_title>Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azidus Brasil</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azidus Brasil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics&#xD;
      parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following&#xD;
      administration of single subcutaneous dose. The objective of this randomized, crossover,&#xD;
      clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T&#xD;
      produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by&#xD;
      Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa),&#xD;
      as surrogate markers for their circulating concentrations of the drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In addition other pharmacodynamic tests such as Tissue Factor Pathway Inhibitor (TFPI)&#xD;
      activity, as well as the ratio of anti-FXa and anti-FIIa activity will be compared as&#xD;
      secondary objectives.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>anti-FXa</measure>
    <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</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>anti-FIIa activity</measure>
    <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</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tissue Factor Pathway Inhibitor (TFPI)</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ratio of anti-FXa and anti-FIIa activity</measure>
    <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</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Teste</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparador</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Heparin, Low-Molecular-Weight</intervention_name>
    <description>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.</description>
    <arm_group_label>Comparador</arm_group_label>
    <arm_group_label>Teste</arm_group_label>
    <other_name>Clexane</other_name>
    <other_name>Enoxalow</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Agree to all the purposes of the study by signing and dating the Informed Consent;&#xD;
&#xD;
          -  Male, aged between 18 and 55 years, clinically healthy;&#xD;
&#xD;
          -  BMI between 18.5 and 30;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in clinical trials in the 12 months preceding the trial;&#xD;
&#xD;
          -  Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal,&#xD;
             genitourinary or other systems diseases;&#xD;
&#xD;
          -  Acute disease in the period of 07 days before the beginning of the practical phase&#xD;
             (administration of the drug) of the study;&#xD;
&#xD;
          -  Chronic administration of medications for hypertension, diabetes or any other disease&#xD;
             that requires continuous use of any drug;&#xD;
&#xD;
          -  Hemoglobin &lt; 13 g/dL;&#xD;
&#xD;
          -  Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory drugs;&#xD;
&#xD;
          -  Use of medications that interact with enoxaparin;&#xD;
&#xD;
          -  History of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism that&#xD;
             may interfere with the clinical outcome of the study;&#xD;
&#xD;
          -  History of coagulopathy and bleeding diathesis;&#xD;
&#xD;
          -  Presence of changes in physical examination suggestive of coagulation disorders&#xD;
             (bruising, petechiae, or bruising);&#xD;
&#xD;
          -  Changes in the skin or subcutaneous tissue of the place of drug administration(eg&#xD;
             liposuction in the abdomen);&#xD;
&#xD;
          -  Absolute platelet count below 100 x 109 / L;&#xD;
&#xD;
          -  History of chronic bleeding;&#xD;
&#xD;
          -  History of acute haemorrhage in the past 30 days;&#xD;
&#xD;
          -  History of sensitivity to mammalian-derived biological products, albumin or any&#xD;
             component of the formulation;&#xD;
&#xD;
          -  History of allergy or Steven Johnson disease;&#xD;
&#xD;
          -  Current or previous history (under 12 months) use of illicit drugs and tobacco;&#xD;
&#xD;
          -  History of alcohol abuse, current or previous (within 12 months);&#xD;
&#xD;
          -  At the discretion of the Principal Investigator of the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre Frederico</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azidus Brasil</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LAL Clinica</name>
      <address>
        <city>Valinhos</city>
        <state>Sao Paulo</state>
        <zip>13276-245</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>subjects</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    <mesh_term>Tinzaparin</mesh_term>
    <mesh_term>Dalteparin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01692158
org study id: ENOBLA0512SC-I
secondary id: Versão 01 datada de 15.05.2012
nct id: NCT01692158
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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
measure: 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
measure: 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
measure: 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
arm group label: Teste
arm group type: Experimental
description: Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.
arm group label: Comparador
arm group type: Active Comparator
description: Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis
intervention type: Drug
intervention name: Heparin, Low-Molecular-Weight
description: 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.
arm group label: Comparador
arm group label: Teste
other name: Clexane
other name: Enoxalow
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexandre Frederico
role: Principal Investigator
affiliation: Azidus Brasil
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Heparin
mesh term: Heparin, Low-Molecular-Weight
mesh term: Tinzaparin
mesh term: Dalteparin