<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/NCT04420234</url>
  </required_header>
  <id_info>
    <org_study_id>SYSS-Remitch-HD-I-01</org_study_id>
    <nct_id>NCT04420234</nct_id>
  </id_info>
  <brief_title>A Pharmacokinetics and Safety Study of Narfurine Hydrochloride Orally Disintegrating Tablets</brief_title>
  <official_title>A Single-center Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Single and Multiple Oral Administration of Narfurine Hydrochloride Orally Disintegrating Tablets in Chinese Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shenyang Sunshine Pharmaceutical Co., LTD.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital of Zhejiang University</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>
      Main objective: To evaluate the pharmacokinetics of single and multiple oral administration&#xD;
      of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.&#xD;
&#xD;
      Secondary objective: To evaluate the safety profile of single and multiple oral&#xD;
      administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy&#xD;
      adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Actual">July 28, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC AUC</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Area Under the Plasma Concentration-time Curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Maximum Observed Plasma Concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Time to Reach the Maximum Plasma Concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Elimination half-life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kel</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Elimination rate constant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F CL/F</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Apparent clearance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vd/F</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Apparent distribution volume based on terminal elimination phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRT</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Mean residence time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Css_max</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Steady state peak concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Css_min</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Steady state Valley concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Css_av</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Steady state average concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DF</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>Volatility index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerance indicators</measure>
    <time_frame>Day1 to Day13</time_frame>
    <description>AE and SAE</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Improvement of Pruritus in Hemodialysis Patients</condition>
  <arm_group>
    <arm_group_label>Pharmacokinetics study of single and multiple administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the study session, 30 healthy subjects will be administered a single and multiple dose of narfurine hydrochloride orally disintegrating tablets 5 µg (2.5 µg/table) to evaluate the pharmacokinetic parameters and the safety profile.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>narfurine hydrochloride orally disintegrating tablets</intervention_name>
    <description>Subjects swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM on D1; swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM starting on D4. Dosing for 7 consecutive days (D10 last dose in the morning).</description>
    <arm_group_label>Pharmacokinetics study of single and multiple administration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years old &lt;= age &lt;= 40 years old, male or female;&#xD;
&#xD;
          2. Weight: male &gt;= 50 kg, female &gt;= 45 kg; body mass index (BMI) in the range of 19-26 kg&#xD;
             / m2 (including 19 and 26);&#xD;
&#xD;
          3. Important indicators including physical examination, vital signs examination,&#xD;
             electrocardiogram examination, laboratory examination, and chest X-ray examination are&#xD;
             normal or within the acceptable range of the sponsors or researchers;&#xD;
&#xD;
          4. During the trial and within 3 months after the last medication, there is no parenting&#xD;
             plan and reliable contraceptive measures could be taken;&#xD;
&#xD;
          5. Fully understand the purpose and requirements of this trial, voluntarily participate&#xD;
             in clinical trials and sign a written informed consent form, and can complete the&#xD;
             entire trial process according to the trial requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those who are known to have a history of allergies, allergic diseases or allergies to&#xD;
             the test preparation and any of its components or related preparations;&#xD;
&#xD;
          2. Those who have a clear medical history of the central nervous system, cardiovascular&#xD;
             system, digestive system, respiratory system, urinary system, blood system, metabolic&#xD;
             disorders or serious infections and serious injuries, or other diseases that are not&#xD;
             suitable for participating in clinical trials (such as history of mental illness,&#xD;
             etc.)&#xD;
&#xD;
          3. Those who have donated blood or lost blood &gt;= 400mL within 3 months before enrollment;&#xD;
&#xD;
          4. Those who have taken any drugs (including prescription drugs and over-the-counter&#xD;
             drugs), vitamins, and Chinese herbal medicines within 2 weeks before screening;&#xD;
&#xD;
          5. Those who have participated in clinical trials of other drugs or medical devices&#xD;
             within 3 months before being selected;&#xD;
&#xD;
          6. Those who is or was a drug addict or positive in drug abuse screening test;&#xD;
&#xD;
          7. Those who is or was an alcoholic (drinking more than 14 standard units per week. 1&#xD;
             standard unit contains 14g alcohol, such as 360mL beer or 45mL spirits with 40%&#xD;
             alcohol or 150mL wine), or positive in urine alcohol test.&#xD;
&#xD;
          8. Smokers or those with an average daily smoking volume of more than 5 cigarettes within&#xD;
             3 months before screening, and those with a positive nicotine test;&#xD;
&#xD;
          9. Those who is positive in Hepatitis B surface antigen (HBsAg), HCV antibody, Treponema&#xD;
             pallidum antibody and HIV antibody;&#xD;
&#xD;
         10. Female subjects who are in the lactation period or is positive in the pregnancy test&#xD;
             during the screening period or clinical trial;&#xD;
&#xD;
         11. Those who have used any drugs that is CYP3A4 inhibitor or inducer within 4 weeks&#xD;
             before signing the informed consent form, see Appendix 3 for details;&#xD;
&#xD;
         12. People with long-term insomnia and those with the habit of taking sleeping pills;&#xD;
&#xD;
         13. People with habitual constipation;&#xD;
&#xD;
         14. Those who is diagnosed abnormal or with clinical significance in physical examination,&#xD;
             vital signs examination, electrocardiogram or clinical laboratory examination, etc.,&#xD;
&#xD;
         15. Those who have undergone surgery that can affect the absorption, distribution,&#xD;
             metabolism, excretion of drugs, or have any gastrointestinal diseases that may affect&#xD;
             the absorption of drugs, or those who are determined by the investigator to be&#xD;
             unsuitable for enrollment;&#xD;
&#xD;
         16. Those who consume excessive amounts of tea, coffee and / or caffeinated beverages&#xD;
             (more than 8 cups, 1 cup = 250mL) every day within 30 days before screening&#xD;
&#xD;
         17. Those who took grapefruit or grapefruit juice and drinks or foods containing St.&#xD;
             John's wort (hypericum perforatum), ginseng, ginkgo, valerian, and echinacea within 48&#xD;
             hours before administration;&#xD;
&#xD;
         18. Those who is diagnosed abnormal or have clinical significance by researchers in the&#xD;
             chest X-ray examination;&#xD;
&#xD;
         19. Those who develop new diseases during the pre-study screening stage or before study&#xD;
             medication;&#xD;
&#xD;
         20. Those who cannot tolerate venipuncture blood collection;&#xD;
&#xD;
         21. Those who are thought to be unsuitable for participating in the trial by the&#xD;
             researchers because of other factors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jian liu, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital,ZheJiang Univercity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital,ZheJiang Univercity</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>narfurine hydrochloride orally disintegrating tablets</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pruritus</mesh_term>
  </condition_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/NCT04420234
org study id: SYSS-Remitch-HD-I-01
nct id: NCT04420234
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Main objective: To evaluate the pharmacokinetics of single and multiple oral administration
      of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.

      Secondary objective: To evaluate the safety profile of single and multiple oral
      administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy
      adult subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC AUC
time frame: Day1 to Day13
description: Area Under the Plasma Concentration-time Curve
measure: Cmax
time frame: Day1 to Day13
description: Maximum Observed Plasma Concentration
measure: Tmax
time frame: Day1 to Day13
description: Time to Reach the Maximum Plasma Concentration
measure: t1/2
time frame: Day1 to Day13
description: Elimination half-life
measure: Kel
time frame: Day1 to Day13
description: Elimination rate constant
measure: CL/F CL/F
time frame: Day1 to Day13
description: Apparent clearance
measure: Vd/F
time frame: Day1 to Day13
description: Apparent distribution volume based on terminal elimination phase
measure: MRT
time frame: Day1 to Day13
description: Mean residence time
measure: Css_max
time frame: Day1 to Day13
description: Steady state peak concentration
measure: Css_min
time frame: Day1 to Day13
description: Steady state Valley concentration
measure: Css_av
time frame: Day1 to Day13
description: Steady state average concentration
measure: DF
time frame: Day1 to Day13
description: Volatility index
measure: Safety and tolerance indicators
time frame: Day1 to Day13
description: AE and SAE
arm group label: Pharmacokinetics study of single and multiple administration
arm group type: Experimental
description: During the study session, 30 healthy subjects will be administered a single and multiple dose of narfurine hydrochloride orally disintegrating tablets 5 µg (2.5 µg/table) to evaluate the pharmacokinetic parameters and the safety profile.
intervention type: Drug
intervention name: narfurine hydrochloride orally disintegrating tablets
description: Subjects swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM on D1; swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM starting on D4. Dosing for 7 consecutive days (D10 last dose in the morning).
arm group label: Pharmacokinetics study of single and multiple administration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: jian liu, master
role: Principal Investigator
affiliation: The First Affiliated Hospital,ZheJiang Univercity
facility: 
country: China
responsible party type: Sponsor
mesh term: Pruritus
sharing ipd: No