<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/NCT01685359</url>
  </required_header>
  <id_info>
    <org_study_id>EPOBLA0612IV-I2</org_study_id>
    <secondary_id>Version 1 25/06/2012</secondary_id>
    <nct_id>NCT01685359</nct_id>
  </id_info>
  <brief_title>PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant</brief_title>
  <official_title>Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Human Recombinant Epoetin (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 (Human Recombiant Epoetin - Blau)&#xD;
      pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®&#xD;
      - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose.&#xD;
      The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic&#xD;
      and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau&#xD;
      Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing&#xD;
      plasma concentration of the drug and the reticulocyte count following a multiple intravenous&#xD;
      administration during 4 weeks of 100 IU/kg in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2013</start_date>
  <completion_date type="Actual">October 31, 2013</completion_date>
  <primary_completion_date type="Actual">October 31, 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 last drug 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 frameon day 29: 72h +/- 2h after last drug administration.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Test Drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test Drug (Human Recombinant Epoetin alfa - Blau) dosage: 100 IU/kg intravenous administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eprex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eprex (Janssen-Cilag, Epoetin alfa) dosage: 100 IU/kg intravenous administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epoetin Alfa</intervention_name>
    <description>Intravenous administration for 4 weeks, three times a week (monday, wednesday, friday)</description>
    <arm_group_label>Eprex</arm_group_label>
    <arm_group_label>Test Drug</arm_group_label>
    <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>
  <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>July 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01685359
org study id: EPOBLA0612IV-I2
secondary id: Version 1 25/06/2012
nct id: NCT01685359
lead sponsor: 
has dmc: Yes
The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau)
      pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®
      - Janssen-Cilag) 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 Human Reconbiant Epoetin produced 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 last drug 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 frameon day 29: 72h +/- 2h after last drug administration.
arm group label: Test Drug
arm group type: Experimental
description: Test Drug (Human Recombinant Epoetin alfa - Blau) dosage: 100 IU/kg intravenous administration
arm group label: Eprex
arm group type: Active Comparator
description: Eprex (Janssen-Cilag, Epoetin alfa) dosage: 100 IU/kg intravenous administration
intervention type: Drug
intervention name: Epoetin Alfa
description: Intravenous administration for 4 weeks, three times a week (monday, wednesday, friday)
arm group label: Eprex
arm group label: Test Drug
other name: Eprex
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Epoetin Alfa