<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/NCT01664221</url>
  </required_header>
  <id_info>
    <org_study_id>EPOBLA0412IV-I</org_study_id>
    <secondary_id>Version 1 09/04/2012</secondary_id>
    <nct_id>NCT01664221</nct_id>
  </id_info>
  <brief_title>PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects.</brief_title>
  <official_title>Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Eritromax (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study.</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 (Eritromax ®) pharmacokinetics and&#xD;
      pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects&#xD;
      following administration of multiple intravenous dose. The objective of this randomized,&#xD;
      parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of&#xD;
      the test drug Eritromax® marketed by Blau Farmacêutica, compared to the comparator drug&#xD;
      Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the&#xD;
      reticulocyte count following a multiple intravenous administration during 4 weeks of 100&#xD;
      IU/kg in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">October 2013</completion_date>
  <primary_completion_date type="Anticipated">October 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rHuEPO serum concentration</measure>
    <time_frame>1, 8, 15, 19, 22 and 26 days after first administration</time_frame>
    <description>Time frame on days 1, 8, 19 and 22: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h and 12h after administration&#xD;
Time frame on day 26: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 36h after administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>plasma reticulocyte count.</measure>
    <time_frame>1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 and 29 days after first administration of the drug.</time_frame>
    <description>Time frame on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26: 10 minutes before drug administration.&#xD;
Time frame on day 29: 72 hours +/- 2 hours after last drug administration.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Eritromax</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eritromax (Epoetin alfa) intravenous administration, dose: 100 IU/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eprex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eprex (Epoetin alfa) intravenous administration: 100 IU/kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epoetin Alfa</intervention_name>
    <description>Intravenous administration of the drug, test or comparator, for 4 weeks, 3 times a week (monday, wednesday and friday).</description>
    <arm_group_label>Eprex</arm_group_label>
    <arm_group_label>Eritromax</arm_group_label>
    <other_name>Eritromax</other_name>
    <other_name>Eprex</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 20 and 55 years, clinically healthy;&#xD;
&#xD;
          -  BMI between 18.5 and 30;&#xD;
&#xD;
          -  Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;&#xD;
&#xD;
          -  VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000&#xD;
             units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells.&#xD;
&#xD;
          -  Human serum ferritin between 36-262 mcg / L;&#xD;
&#xD;
          -  Counting of reticulocytes in peripheral blood ≤ 3%;&#xD;
&#xD;
          -  Serum erythropoietin &lt; 30 mIU / mL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in clinical trials in the 12 months preceding the survey;&#xD;
&#xD;
          -  Body weight &gt; 100 kg;&#xD;
&#xD;
          -  Presence of iron deficiency anemia;&#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;
          -  Hormone therapy in the period of 02 months preceding the beginning of the practical&#xD;
             phase (administration of the drug) of the study;&#xD;
&#xD;
          -  Administration of any drug in the 02 weeks prior to the start of the practical period&#xD;
             of the study;&#xD;
&#xD;
          -  Clinical history of autoimmune or hereditary anemia;&#xD;
&#xD;
          -  Clinical history of chronic bleeding;&#xD;
&#xD;
          -  Clinical history of acute bleeding in the 30 days preceding the beginning of practical&#xD;
             phase of the study (administration of the drug);&#xD;
&#xD;
          -  Clinical history of allergy of biological products derived from mammalian albumin or&#xD;
             any component of the formulation;&#xD;
&#xD;
          -  Current or previous history (less than 12 months) of illicit drug abuse and / or&#xD;
             tobacco and / or alcohol or having consumed alcohol within 48 hours prior to the&#xD;
             practical study periods (administration of the drug);&#xD;
&#xD;
          -  Prior therapies with erythropoietin;&#xD;
&#xD;
          -  Albumin below 3.5 g/dL or higher than 4.8 g/dL;&#xD;
&#xD;
          -  Signs or clinical history of bone marrow aplasia;&#xD;
&#xD;
          -  History and clinical or laboratory liver disease;&#xD;
&#xD;
          -  History and clinical or laboratory nephropathy;&#xD;
&#xD;
          -  Principal Investigator of the study criteria.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alexandre Frederico</last_name>
    <phone>+55 19 38716399</phone>
    <email>alexandre@lalclinica.com.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>LAL Clinica</name>
      <address>
        <city>Valinhos</city>
        <state>Sao Paulo</state>
        <zip>13276-245</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Bruna Franco</last_name>
      <phone>+55 19 38716399</phone>
      <email>bruna.franco@lalclinica.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Nathália Ribeiro</last_name>
      <phone>+55 19 38716399</phone>
      <email>nathalia.ribeiro@lalclinica.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Alexandre Frederico</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>August 10, 2012</last_update_submitted>
  <last_update_submitted_qc>August 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>subject</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</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/NCT01664221
org study id: EPOBLA0412IV-I
secondary id: Version 1 09/04/2012
nct id: NCT01664221
lead sponsor: 
has dmc: Yes
The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and
      pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects
      following administration of multiple intravenous dose. The objective of this randomized,
      parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of
      the test drug Eritromax® marketed by Blau Farmacêutica, compared to the comparator drug
      Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the
      reticulocyte count following a multiple intravenous administration during 4 weeks of 100
      IU/kg in healthy subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: rHuEPO serum concentration
time frame: 1, 8, 15, 19, 22 and 26 days after first administration
description: Time frame on days 1, 8, 19 and 22: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h and 12h after administration
Time frame on day 26: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 36h after administration
measure: plasma reticulocyte count.
time frame: 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 and 29 days after first administration of the drug.
description: Time frame on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26: 10 minutes before drug administration.
Time frame on day 29: 72 hours +/- 2 hours after last drug administration.
arm group label: Eritromax
arm group type: Experimental
description: Eritromax (Epoetin alfa) intravenous administration, dose: 100 IU/kg
arm group label: Eprex
arm group type: Active Comparator
description: Eprex (Epoetin alfa) intravenous administration: 100 IU/kg
intervention type: Drug
intervention name: Epoetin Alfa
description: Intravenous administration of the drug, test or comparator, for 4 weeks, 3 times a week (monday, wednesday and friday).
arm group label: Eprex
arm group label: Eritromax
other name: Eritromax
other name: Eprex
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexandre Frederico
phone: +55 19 38716399
email: alexandre@lalclinica.com.br
facility: 
contact: 
contact backup: 
investigator: 
country: Brazil
responsible party type: Sponsor
mesh term: Epoetin Alfa