<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/NCT04486157</url>
  </required_header>
  <id_info>
    <org_study_id>IN_FNP_101</org_study_id>
    <nct_id>NCT04486157</nct_id>
  </id_info>
  <brief_title>Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects</brief_title>
  <official_title>A Phase 1, Open Label, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Crossover Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HK inno.N Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HK inno.N Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and&#xD;
      Akynzeo capsules by pharmacokinetic(PK) evaluation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      [Pharmacokinetics Assessment]&#xD;
&#xD;
        -  Primary Parameter&#xD;
&#xD;
           - AUC0-t&#xD;
&#xD;
        -  Secondary Parameters - Cmax, tmax&#xD;
&#xD;
      [Safety Assessment]&#xD;
&#xD;
      - Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory&#xD;
      tests&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2021</start_date>
  <completion_date type="Actual">May 10, 2021</completion_date>
  <primary_completion_date type="Actual">April 26, 2021</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-t of netupitant</measure>
    <time_frame>pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose</time_frame>
    <description>Area under the plasma concentration versus time curve of netupitant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron</measure>
    <time_frame>pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose</time_frame>
    <description>Peak Plasma Concentration of fosnetupitant, netupitant metabolites and palonosetron</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron</measure>
    <time_frame>pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose</time_frame>
    <description>Time to reach maximum (peak) plasma concentration of fosnetupitant, netupitant, netupitant metabolites and palonosetron</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>IN-A012</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous administration of IN-A012</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Akynzeo capsules</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single oral administration of Akynzeo capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IN-A012</intervention_name>
    <description>The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.</description>
    <arm_group_label>IN-A012</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Akynzeo 300Mg-0.5Mg Capsule</intervention_name>
    <description>The subjects will be administrated Akynzeo by Orally with water.</description>
    <arm_group_label>Akynzeo capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adults aged between 19-45&#xD;
&#xD;
          2. Body weight ≥ 50kg and in the range of ideal body weight ± 20%&#xD;
&#xD;
          3. Without congenital, or chronic diseases within recent 5 years&#xD;
&#xD;
          4. Subjects who are deemed eligible based on the screening tests&#xD;
&#xD;
          5. Subjects who received a full explanation of the study, understood the purpose and&#xD;
             details of this study, characteristics of the investigational product, and expected&#xD;
             adverse events, and voluntarily signed the informed consent form&#xD;
&#xD;
          6. Agree to use acceptable contraceptive methods from signing the informed consent to 3&#xD;
             weeks after the last dose of the investigational product&#xD;
&#xD;
          7. Able and willing to comply with study requirements including all scheduled inpatient&#xD;
             and outpatient visits, clinical laboratory tests, and instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A subject with symptoms suspected of acute illness at the screening&#xD;
&#xD;
          2. A subject with clinically significant and active cardiovascular, respiratory, kidney,&#xD;
             endocrine, hematological, gastrointestinal, central nervous system diseases,&#xD;
             psychiatric disorders, or malignant tumors&#xD;
&#xD;
          3. A history of gastrointestinal disease&#xD;
&#xD;
          4. Known hypersensitivity to the active ingredient or excipients of investigational&#xD;
             product or a history of clinically significant hypersensitivity&#xD;
&#xD;
          5. A history of drug abuse&#xD;
&#xD;
          6. Pregnant women or women who may be pregnant, and breastfeeding women&#xD;
&#xD;
          7. Subjects who are deemed inappropriate to participate in the study by the investigator&#xD;
             for other reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seunghoon Han</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Catholic University of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Catholic Univ. of Seoul St. Mary's 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 2021</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>May 28, 2021</last_update_submitted>
  <last_update_submitted_qc>May 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04486157
org study id: IN_FNP_101
nct id: NCT04486157
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and
      Akynzeo capsules by pharmacokinetic(PK) evaluation
[Pharmacokinetics Assessment]

        -  Primary Parameter

           - AUC0-t

        -  Secondary Parameters - Cmax, tmax

      [Safety Assessment]

      - Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory
      tests
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: AUC0-t of netupitant
time frame: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
description: Area under the plasma concentration versus time curve of netupitant
measure: Cmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron
time frame: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
description: Peak Plasma Concentration of fosnetupitant, netupitant metabolites and palonosetron
measure: tmax of fosnetupitant, netupitant, netupitant metabolites and palonosetron
time frame: pre-dose(0hour), 0.5, 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 , 120, 144, 168, 192, 216, and 240 hours post-dose
description: Time to reach maximum (peak) plasma concentration of fosnetupitant, netupitant, netupitant metabolites and palonosetron
arm group label: IN-A012
arm group type: Experimental
description: Intravenous administration of IN-A012
arm group label: Akynzeo capsules
arm group type: Active Comparator
description: Single oral administration of Akynzeo capsules
intervention type: Drug
intervention name: IN-A012
description: The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.
arm group label: IN-A012
intervention type: Drug
intervention name: Akynzeo 300Mg-0.5Mg Capsule
description: The subjects will be administrated Akynzeo by Orally with water.
arm group label: Akynzeo capsules
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Seunghoon Han
role: Principal Investigator
affiliation: The Catholic University of Korea
facility: 
country: Korea, Republic of
responsible party type: Sponsor