<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/NCT01685671</url>
  </required_header>
  <id_info>
    <org_study_id>136HPS12C</org_study_id>
    <nct_id>NCT01685671</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics Study of CKD-11101 and NESP After SC Administration in Health Male Volunteers</brief_title>
  <official_title>A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After SC Administration in Health Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after&#xD;
      SC administration in health male volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once subcutaneously.&#xD;
      (crossover) Every time before and after taking each medication, PK parameters and safety of&#xD;
      CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some&#xD;
      tests(Laboratory test, V/S and Physical Examination, etc) respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2012</start_date>
  <completion_date type="Actual">January 15, 2013</completion_date>
  <primary_completion_date type="Actual">December 25, 2012</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess AUClast of darbepoetin alfa</measure>
    <time_frame>Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess Cmax of darbepoetin alfa</measure>
    <time_frame>Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess AUCinf of darbepoetin alfa</measure>
    <time_frame>Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess Tmax of darbepoetin alfa</measure>
    <time_frame>Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess t1/2 of darbepoetin alfa</measure>
    <time_frame>Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess CL of darbepoetin alfa</measure>
    <time_frame>Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>NESP 60μg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prefilled syringe filled with Darbepoetin alfa 60μg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CKD-11101 60μg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prefilled syringe filled with Darbepoetin alfa 60μg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NESP 60μg</intervention_name>
    <description>Administrated NESP 60μg once subcutaneously</description>
    <arm_group_label>NESP 60μg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-11101 60μg</intervention_name>
    <description>Administrated CKD-11101 60μg once subcutaneously</description>
    <arm_group_label>CKD-11101 60μg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed the informed consent form prior to study participation.&#xD;
&#xD;
          -  A healthy male volunteer between 20 and 55 years old.&#xD;
&#xD;
          -  Body weight between 55kg and 90kg, BMI between 18 and 27.&#xD;
&#xD;
          -  Appropriate subject for the study judging from investigator(physical examination,&#xD;
             laboratory test, interview, etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have the medical history of allergic diseases including hypersensitivity against drug&#xD;
             or clinically significant allergic diseases&#xD;
&#xD;
          -  Clinically significant hepatic, renal, respiratory system, endocrine system, nervous&#xD;
             system, immune system, hematologic, psychiatric, circulatory system, tumor or have&#xD;
             history of tumor&#xD;
&#xD;
          -  Have abnormal laboratory result.&#xD;
&#xD;
               -  Hemoglobin &lt; 12g/dL or &gt; 17g/dL&#xD;
&#xD;
               -  Vitamin B12 &lt; 200pg/mL&#xD;
&#xD;
               -  Ferritin &lt; 21.8ng/mL&#xD;
&#xD;
               -  Transferrin &lt; 190mg/dL&#xD;
&#xD;
               -  Reticulocyte over the normal limit&#xD;
&#xD;
               -  Positive for the Triage TOX drug on urine (cocaine, amphetamines, barbiturates,&#xD;
                  opiates, benzodiazepine, cannabinoids)&#xD;
&#xD;
               -  Positive for HIV antibody, HBsAg, HCV antibody test&#xD;
&#xD;
          -  A heavy smoker (cigarette &gt; 10 cigarettes per day)&#xD;
&#xD;
          -  Administer EPO, darbepoetin, immunoglobulin or IV iron within 3 months prior to the&#xD;
             first IP administration&#xD;
&#xD;
          -  Have hypersensitivity reactions history for EPO, darbepoetin, excipient of IP or iron&#xD;
             tablets&#xD;
&#xD;
          -  sit SBP &lt; 90mmHg or sit SBP &gt; 140mmHg or sit DBP &lt; 55mmHg or sit DBP &gt; 90mmHg or Pulse&#xD;
             rate &gt; 100 per/min&#xD;
&#xD;
          -  History of hemoglobinopathy or inflammatory disease or drug abuse within 6 months&#xD;
             before screening&#xD;
&#xD;
          -  Subject takes ethical drug or herbal medicine within 14 days, OTC or vitamin&#xD;
             supplements within 7 days before the first IP administration&#xD;
&#xD;
          -  Participated in the other clinical trials and administrated IP within 8 weeks prior to&#xD;
             the first IP administration&#xD;
&#xD;
          -  A heavy alcohol consumer (alcohol &gt; 21 units/week) or cannot stop drinking&#xD;
&#xD;
          -  Bleed or donate blood (&gt; 400mL) within 8 weeks before the first IP administration&#xD;
&#xD;
          -  Participated in this clinical trials and administrated IP&#xD;
&#xD;
          -  Have a diet within 2 days before the first IP administration or cannot stop having&#xD;
&#xD;
               -  food containing grapefruit&#xD;
&#xD;
               -  food containing caffeine&#xD;
&#xD;
          -  Disagree to avoid getting pregnant during clinical trial&#xD;
&#xD;
          -  An impossible one who participates in clinical trial by investigator's decision&#xD;
             including laboratory test result, other reason&#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_official>
    <last_name>Kyung Sang Yu, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul national university hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>May 22, 2017</last_update_submitted>
  <last_update_submitted_qc>May 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CKD-11101</keyword>
  <keyword>NESP</keyword>
  <keyword>Darbepoetin alfa</keyword>
  <keyword>Anemia</keyword>
  <keyword>subcutaneous</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Phase 1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
  </condition_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/NCT01685671
org study id: 136HPS12C
nct id: NCT01685671
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after
      SC administration in health male volunteers
Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once subcutaneously.
      (crossover) Every time before and after taking each medication, PK parameters and safety of
      CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some
      tests(Laboratory test, V/S and Physical Examination, etc) respectively.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Assess AUClast of darbepoetin alfa
time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
measure: Assess Cmax of darbepoetin alfa
time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
measure: Assess AUCinf of darbepoetin alfa
time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
measure: Assess Tmax of darbepoetin alfa
time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
measure: Assess t1/2 of darbepoetin alfa
time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
measure: Assess CL of darbepoetin alfa
time frame: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
arm group label: NESP 60μg
arm group type: Active Comparator
description: Prefilled syringe filled with Darbepoetin alfa 60μg
arm group label: CKD-11101 60μg
arm group type: Experimental
description: Prefilled syringe filled with Darbepoetin alfa 60μg
intervention type: Drug
intervention name: NESP 60μg
description: Administrated NESP 60μg once subcutaneously
arm group label: NESP 60μg
intervention type: Drug
intervention name: CKD-11101 60μg
description: Administrated CKD-11101 60μg once subcutaneously
arm group label: CKD-11101 60μg
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kyung Sang Yu, Ph.D
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Anemia