xml: <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/NCT06005714</url>
    </required_header>
    <id_info>
      <org_study_id>JT001-018-I</org_study_id>
      <nct_id>NCT06005714</nct_id>
    </id_info>
    <brief_title>Effect of Pharmacokinetics in Healthy Chinese Subjects</brief_title>
    <official_title>Effect of Clarithromycin or Cyclosporine on Pharmacokinetics of Deuterium Hydrobromide Ramidvir Tablets in Healthy Chinese Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Vinnerna Biosciences Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Vinnerna Biosciences Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a single-center, open label, self-controlled phase I clinical study, to&#xD;
        evaluate the effects of clarithromycin or cyclosporine on pharmacokinetics of deuterium&#xD;
        hydrobromide ramidvir tablets in healthy Chinese subjects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>AUC0-t of 116-N1</measure>
      <time_frame>At pre-defined intervals up to 14 days</time_frame>
      <description>Area under the curve from time zero to the time of the t(AUC0-t ) of 116-N1</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum Plasma Concentration (Cmax) of 116-N1</measure>
      <time_frame>At pre-defined intervals up to 14 days</time_frame>
      <description>Maximum Plasma Concentration (Cmax) of 116-N1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Half-life(T1/2) of 116-N1</measure>
      <time_frame>At pre-defined intervals up to 14 days</time_frame>
      <description>Half-life(T1/2) of 116-N1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clearance(CL) of 116-N1</measure>
      <time_frame>At pre-defined intervals up to 14 days</time_frame>
      <description>Clearance(CL) of 116-N1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax of 116-N1</measure>
      <time_frame>At pre-defined intervals up to 14 days</time_frame>
      <description>Peak time of 116-N1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vz/F of 116-N1</measure>
      <time_frame>At pre-defined intervals up to 14 days</time_frame>
      <description>Apparent volume of distribution of 116-N1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of adverse events including serious adverse events</measure>
      <time_frame>Up to 18 days</time_frame>
      <description>Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">36</enrollment>
    <condition>The Effects of Clarithromycin or Cyclosporine on Pharmacokinetics of Deuterium Hydrobromide Ramidvir Tablets in Healthy Chinese Subjects</condition>
    <arm_group>
      <arm_group_label>The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Mindeudesivir hydrobromide tablets and Clarithromycin tablets</intervention_name>
      <description>Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and clarithromycin tablets are administered twice from D1 to D10.</description>
      <arm_group_label>The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets</arm_group_label>
      <arm_group_label>The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Mindeudesivir hydrobromide tablets and Cyclosporine softgels</intervention_name>
      <description>Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and cyclosporine sofgels are administered once at D4.</description>
      <arm_group_label>The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets</arm_group_label>
      <arm_group_label>The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: 18 years old ≤ age ≤ 45 years old; Gender is not limited;&#xD;
  &#xD;
            2. Weight: male ≥ 50 kg, female ≥ 45 kg; Body mass index (BMI) in the range of 19-26&#xD;
               kg/m2 (including 19 and 26);&#xD;
  &#xD;
            3. Good health status, that is, vital signs, physical examination, laboratory tests,&#xD;
               electrocardiogram and ultrasound examination are normal or abnormal and have no&#xD;
               clinical significance;&#xD;
  &#xD;
            4. Participants who were able to take effective contraceptive measures during the study&#xD;
               and within 3 months after the last dose of investigational product;&#xD;
  &#xD;
            5. Participants who could fully understand the purpose, content and possible adverse&#xD;
               reactions of this study, voluntarily participate in the clinical study and sign the&#xD;
               written informed consent form, and were able to complete the entire study process and&#xD;
               comply with the study regulations in accordance with the requirements of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known history of allergy to the test preparation and any of its components or related&#xD;
               preparations;&#xD;
  &#xD;
            2. Subjects with allergic diseases or allergic constitutions;&#xD;
  &#xD;
            3. Those who have clear diseases of the central nervous system, cardiovascular system,&#xD;
               digestive system, respiratory system, urinary system, blood system, metabolic&#xD;
               disorders, etc., and require medical intervention or other diseases that are not&#xD;
               suitable for participating in clinical trials (such as psychiatric history, etc.);&#xD;
  &#xD;
            4. Those who have donated blood or lost blood ≥ 400 mL within 3 months before enrollment,&#xD;
               or have a history of blood product use;&#xD;
  &#xD;
            5. Those who have participated in clinical trials of other drugs and taken experimental&#xD;
               drugs within 3 months before enrollment;&#xD;
  &#xD;
            6. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal&#xD;
               medicines or health supplements within 2 weeks before screening;&#xD;
  &#xD;
            7. Those who have used any vaccine within 2 weeks prior to screening.&#xD;
  &#xD;
            8. Those who have previously undergone surgery (such as major gastrectomy surgery) that&#xD;
               may affect drug absorption, distribution, metabolism, or excretion, or may have&#xD;
               surgery or hospitalization plans during the estimated test;&#xD;
  &#xD;
            9. Those with a history of drug dependence or abuse within 1 year before screening, or a&#xD;
               positive urine drug screening test;&#xD;
  &#xD;
           10. Those who have used P-gp or BCRP strong inhibitors within 2 weeks before screening&#xD;
               (see Annex 6 of Section 10.6 for details);&#xD;
  &#xD;
           11. Those who have ingested grapefruit juice/grapefruit juice, foods or drinks rich in&#xD;
               methylxanthines (such as coffee, tea, cola, chocolate, functional drinks) within 48&#xD;
               hours before administration, or strenuous exercise and other factors that affect drug&#xD;
               absorption, distribution, metabolism, excretion and other factors;&#xD;
  &#xD;
           12. Alcohol addict within 1 year prior to screening, drinking at least 2 times a day or&#xD;
               more than 14 units per week, or keen on alcoholism (1 unit≈ 200 mL of beer with 5%&#xD;
               alcohol or 25 mL of spirits with 40% alcohol or 85 mL of wine with 12% alcohol);&#xD;
  &#xD;
           13. Those who smoked cigarettes within 1 year before screening, and smoked more than 10&#xD;
               cigarettes or the same amount of tobacco per day;&#xD;
  &#xD;
           14. Those who cannot quit smoking or alcohol during the trial;&#xD;
  &#xD;
           15. Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), treponemal&#xD;
               antibody and HIV antibody positive;&#xD;
  &#xD;
           16. Chest X-ray (positive and lateral view) results are abnormal and clinically&#xD;
               significant;&#xD;
  &#xD;
           17. At screening or baseline alanine aminotransferase (ALT) or glutamate aminotransferase&#xD;
               (AST) exceeding the upper limit of normal (ULN);&#xD;
  &#xD;
           18. Glomerular filtration rate (eGFR) at screening or baseline &lt; 80 mL/min/1.73m2;&#xD;
  &#xD;
           19. Abnormal ECG at screening or baseline, a single QTcF (mean of QT interval corrected by&#xD;
               Fridericia formula) &gt; 450 ms for men and 470 ms &gt;for women, and/or other abnormalities&#xD;
               of clinical significance;&#xD;
  &#xD;
           20. Pregnant or lactating women or male subjects' spouses who have childcare plans within&#xD;
               3 months;&#xD;
  &#xD;
           21. Those who have other factors that the investigator believes are not suitable for&#xD;
               participation in the trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shuang Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zhengzhou Sixth People's Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Zhengzhou Sixth People's Hospital</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</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>Cyclosporine</mesh_term>
      <mesh_term>Clarithromycin</mesh_term>
      <mesh_term>Cyclosporins</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005714
  org study id: JT001-018-I
  nct id: NCT06005714
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a single-center, open label, self-controlled phase I clinical study, to
        evaluate the effects of clarithromycin or cyclosporine on pharmacokinetics of deuterium
        hydrobromide ramidvir tablets in healthy Chinese subjects.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: AUC0-t of 116-N1
  time frame: At pre-defined intervals up to 14 days
  description: Area under the curve from time zero to the time of the t(AUC0-t ) of 116-N1
  measure: Maximum Plasma Concentration (Cmax) of 116-N1
  time frame: At pre-defined intervals up to 14 days
  description: Maximum Plasma Concentration (Cmax) of 116-N1
  measure: Half-life(T1/2) of 116-N1
  time frame: At pre-defined intervals up to 14 days
  description: Half-life(T1/2) of 116-N1
  measure: Clearance(CL) of 116-N1
  time frame: At pre-defined intervals up to 14 days
  description: Clearance(CL) of 116-N1
  measure: Tmax of 116-N1
  time frame: At pre-defined intervals up to 14 days
  description: Peak time of 116-N1
  measure: Vz/F of 116-N1
  time frame: At pre-defined intervals up to 14 days
  description: Apparent volume of distribution of 116-N1
  measure: Incidence and severity of adverse events including serious adverse events
  time frame: Up to 18 days
  description: Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
  arm group label: The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets
  arm group type: Experimental
  arm group label: The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets
  arm group type: Experimental
  intervention type: Drug
  intervention name: Mindeudesivir hydrobromide tablets and Clarithromycin tablets
  description: Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and clarithromycin tablets are administered twice from D1 to D10.
  arm group label: The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets
  arm group label: The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets
  intervention type: Drug
  intervention name: Mindeudesivir hydrobromide tablets and Cyclosporine softgels
  description: Mindeudesivir hydrobromide tablets are administered once at D1 and D4, and cyclosporine sofgels are administered once at D4.
  arm group label: The effects of clarithromycin on pharmacokinetics of deuterium hydrobromide ramidvir tablets
  arm group label: The effects of cyclosporine on pharmacokinetics of deuterium hydrobromide ramidvir tablets
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shuang Li
  role: Principal Investigator
  affiliation: Zhengzhou Sixth People's Hospital
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Cyclosporine
  mesh term: Clarithromycin
  mesh term: Cyclosporins