<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/NCT03765944</url>
  </required_header>
  <id_info>
    <org_study_id>NPC-12T-1</org_study_id>
    <nct_id>NCT03765944</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets</brief_title>
  <official_title>A Single Dose, Randomized, Open-label, 2-Period, 2-way Crossover, Bioequivalence Study of Sirolimus Granules and Sirolimus Tablets in Japanese Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nobelpharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nobelpharma</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 purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with&#xD;
      NPC-12T tablets in Japanese healthy Adults&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">December 29, 2018</completion_date>
  <primary_completion_date type="Actual">December 29, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood sirolimus concentration</measure>
    <time_frame>Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)</time_frame>
    <description>Whole blood concentration of sirolimus will be measured and compared between NPC-12 granules and NPC-12T tablets.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Bioequivalence Study</condition>
  <arm_group>
    <arm_group_label>NPC-12 granule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NPC-12 granules (1.0g: 2mg sirolimus)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NPC-12T tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NPC-12T 2 tablets (2mg sirolimus)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sirolimus</intervention_name>
    <description>SIngle administration under fasted condition</description>
    <arm_group_label>NPC-12 granule</arm_group_label>
    <arm_group_label>NPC-12T tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Japanese healthy subjects aged 20 to 39 years of age&#xD;
&#xD;
          2. Subjects with BMI ≥ 18.5 kg/m2 and &lt; 25.0 kg/m2&#xD;
&#xD;
          3. Subjects who are considered by the investigator as suitable for participation in the&#xD;
             trial from lab test results at screening&#xD;
&#xD;
          4. Subjects who are considered by the investigator as suitable for participation in the&#xD;
             trial from lab test results on the day before administration&#xD;
&#xD;
          5. Subjects who write informed consent&#xD;
&#xD;
          6. Subjects who are able to comply with the study requirements during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have a history of hypersensitivity to sirolimus or sirolimus derivative&#xD;
&#xD;
          2. Subjects who have a history of hypersensitivity or allergies to other drug&#xD;
&#xD;
          3. SUbjects who have an acute or chronic infectious diseases&#xD;
&#xD;
          4. Subjects who have a current or a history of disease which is considered inappropriate&#xD;
             to be involved in the study, or who has any current disease to require treatments&#xD;
&#xD;
          5. Subjects who have diagnosed with alcoholism or a history of alcoholism&#xD;
&#xD;
          6. Subjects who have an abnormal findings (pneumonia, etc) from the result of chest CT at&#xD;
             screening&#xD;
&#xD;
          7. Subjects who have been administered other investigational drug within 12 weeks before&#xD;
             the initial administration&#xD;
&#xD;
          8. Subjects who have performed blood collection or donation as follows&#xD;
&#xD;
               -  Collected or donated 200 ml or more whole blood within 4 weeks before the initial&#xD;
                  administration&#xD;
&#xD;
               -  Male subject; collected or donated more than 400 mL whole blood within 12 weeks&#xD;
                  before the initial administration&#xD;
&#xD;
               -  Female subjects; collected or donated more than 400 mL whole blood within 16&#xD;
                  weeks before the initial administration&#xD;
&#xD;
               -  Collected or donated blood component within 2 weeks before the initial&#xD;
                  administration&#xD;
&#xD;
          9. Subjects who have positive results for HBs antigen, HBs antibody, HBc antibody, HCV&#xD;
             antibody, HIV antigen/antibody, or syphilis&#xD;
&#xD;
         10. Subjects who received any non-prescription or prescription drug within 12 weeks before&#xD;
             the initial administration&#xD;
&#xD;
         11. Subjects who are pregnant/lactating, or do not agree to contraception during the&#xD;
             period from the screening until 8 weeks after the final administration due to planning&#xD;
             to become pregnant&#xD;
&#xD;
         12. Subjects who cannot speak, read and write in Japanese&#xD;
&#xD;
         13. Subjects who are considered by the investigator as unsuitable for participation in the&#xD;
             trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinique Soigner</name>
      <address>
        <city>Matsudo</city>
        <state>Chiba</state>
        <zip>270 -2231</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2019</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>Sirolimus</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03765944
org study id: NPC-12T-1
nct id: NCT03765944
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with
      NPC-12T tablets in Japanese healthy Adults
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Blood sirolimus concentration
time frame: Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)
description: Whole blood concentration of sirolimus will be measured and compared between NPC-12 granules and NPC-12T tablets.
arm group label: NPC-12 granule
arm group type: Active Comparator
description: NPC-12 granules (1.0g: 2mg sirolimus)
arm group label: NPC-12T tablet
arm group type: Active Comparator
description: NPC-12T 2 tablets (2mg sirolimus)
intervention type: Drug
intervention name: sirolimus
description: SIngle administration under fasted condition
arm group label: NPC-12 granule
arm group label: NPC-12T tablet
criteria: 
gender: All
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Sirolimus
sharing ipd: No