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/NCT06031454</url>
    </required_header>
    <id_info>
      <org_study_id>RAY1216-23-05</org_study_id>
      <nct_id>NCT06031454</nct_id>
    </id_info>
    <brief_title>Drug-durg Interaction of Leritrelvir With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin</brief_title>
    <official_title>A Open-Label, Two-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of Leritrelvir With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin in Healthy Participates</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangdong Raynovent Biotech Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guangdong Raynovent Biotech Co., Ltd</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 drug-drug interaction study had been designed to investigate the effect of Leritrelvir on&#xD;
        the pharmacokinetics of Midazolam, Omeprazole, Rosuvastatin and the effect of Verapamil and&#xD;
        Rifampin on the pharmacokinetics of Leritrelvir&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 20, 2023</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>Sequential Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pharmacokinetic - Cmax</measure>
      <time_frame>0-72 hours</time_frame>
      <description>Maximum observed plasma concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic -Area under the curve（AUC）</measure>
      <time_frame>0-72 hours</time_frame>
      <description>Area under the curve</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with adverse events</measure>
      <time_frame>Day1-Day31</time_frame>
      <description>The safety and tolerability of Leritrelvir alone and in combination with Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin will be examined.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Drug Drug Interaction</condition>
    <arm_group>
      <arm_group_label>Experimental 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participates will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:&#xD;
  Period 1: 1 × 15-mg Midazolam tablet ,1 ×20-mg omeprazole tablet ,1×10-mg rosuvastatin tablet&#xD;
  Period 2: 6 × 400-mg Leritrelvir tablet+1 × 15-mg Midazolam tablet, 1 ×20-mg omeprazole tablet ,1×10-mg rosuvastatin tablet</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participates will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:&#xD;
  Period 1: 1 × 400-mg Leritrelvir tablet&#xD;
  Period 2: 5 × 240-mg verapamil tablet+1 × 400-mg Leritrelvir tablet&#xD;
  Period 3: 8 × 600-mg rifampin capsule +1 × 400-mg Leritrelvir tablet</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Midazolam</intervention_name>
      <description>oral</description>
      <arm_group_label>Experimental 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Omeprazole</intervention_name>
      <description>oral</description>
      <arm_group_label>Experimental 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rosuvastatin</intervention_name>
      <description>oral</description>
      <arm_group_label>Experimental 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Verapamil</intervention_name>
      <description>oral</description>
      <arm_group_label>Experimental 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rifampin</intervention_name>
      <description>oral</description>
      <arm_group_label>Experimental 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Leritrelvir</intervention_name>
      <description>oral</description>
      <arm_group_label>Experimental 1</arm_group_label>
      <arm_group_label>Experimental 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight &gt;50 kg(male) or&#xD;
               &gt;45kg(female) at screening (calculated as a function of measured height and weight&#xD;
               according to the formula, BMI = kg/m2 where m2 is height in meters squared);&#xD;
  &#xD;
            2. Ability to understand and willingness to sign a written informed consent form;&#xD;
  &#xD;
            3. Normal physical examination,vital signs,12-lead ECG, and clinical laboratory values,&#xD;
               or any abnormality that is non-clinically significant.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participates with a history of hypersensitivity to study&#xD;
               drug(Leritrelvir,Midazolam,Omeprazole,Rosuvastatin, Verapamil, and Rifampin) or any&#xD;
               component of study medication;&#xD;
  &#xD;
            2. Participates had taken prescription, over-the-counter, herbal, or vitamin products&#xD;
               within 14 days prior to screening；&#xD;
  &#xD;
            3. Smoking more than 5 cigarettes per day within 3 months prior to screening，or who&#xD;
               cannot stop using any tobacco products during the study period;&#xD;
  &#xD;
            4. Participants who donated blood/bleeding profusely (&gt;400 mL) 3 months prior to&#xD;
               randomization;&#xD;
  &#xD;
            5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF&gt;450ms;&#xD;
  &#xD;
            6. Participates who test positive at screening for human immunodeficiency virus (HIV),&#xD;
               Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis&#xD;
               spirochete-specific antibodies (TPPA);&#xD;
  &#xD;
            7. Participates who test positive at screening and/or admission (Day -1) for alcohol&#xD;
               abuse.&#xD;
  &#xD;
            8. Females who are pregnant, lactating, or likely to become pregnant during the study.&#xD;
  &#xD;
            9. History of dysphagia or any gastrointestinal disorder that affect absorption&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xie Zhihong, Doctor</last_name>
      <phone>+862034152299</phone>
      <email>xzh0302@126.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 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>Rifampin</mesh_term>
      <mesh_term>Verapamil</mesh_term>
      <mesh_term>Midazolam</mesh_term>
      <mesh_term>Omeprazole</mesh_term>
      <mesh_term>Rosuvastatin Calcium</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06031454
  org study id: RAY1216-23-05
  nct id: NCT06031454
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The drug-drug interaction study had been designed to investigate the effect of Leritrelvir on
        the pharmacokinetics of Midazolam, Omeprazole, Rosuvastatin and the effect of Verapamil and
        Rifampin on the pharmacokinetics of Leritrelvir
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Pharmacokinetic - Cmax
  time frame: 0-72 hours
  description: Maximum observed plasma concentration
  measure: Pharmacokinetic -Area under the curve（AUC）
  time frame: 0-72 hours
  description: Area under the curve
  measure: Number of participants with adverse events
  time frame: Day1-Day31
  description: The safety and tolerability of Leritrelvir alone and in combination with Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin will be examined.
  arm group label: Experimental 1
  arm group type: Experimental
  description: All participates will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:
  Period 1: 1 × 15-mg Midazolam tablet ,1 ×20-mg omeprazole tablet ,1×10-mg rosuvastatin tablet
  Period 2: 6 × 400-mg Leritrelvir tablet+1 × 15-mg Midazolam tablet, 1 ×20-mg omeprazole tablet ,1×10-mg rosuvastatin tablet
  arm group label: Experimental 2
  arm group type: Experimental
  description: All participates will receive the following oral doses of study drugs following an overnight fast in the fixed-sequence below:
  Period 1: 1 × 400-mg Leritrelvir tablet
  Period 2: 5 × 240-mg verapamil tablet+1 × 400-mg Leritrelvir tablet
  Period 3: 8 × 600-mg rifampin capsule +1 × 400-mg Leritrelvir tablet
  intervention type: Drug
  intervention name: Midazolam
  description: oral
  arm group label: Experimental 1
  intervention type: Drug
  intervention name: Omeprazole
  description: oral
  arm group label: Experimental 1
  intervention type: Drug
  intervention name: Rosuvastatin
  description: oral
  arm group label: Experimental 1
  intervention type: Drug
  intervention name: Verapamil
  description: oral
  arm group label: Experimental 2
  intervention type: Drug
  intervention name: Rifampin
  description: oral
  arm group label: Experimental 2
  intervention type: Drug
  intervention name: Leritrelvir
  description: oral
  arm group label: Experimental 1
  arm group label: Experimental 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xie Zhihong, Doctor
  phone: +862034152299
  email: xzh0302@126.com
  responsible party type: Sponsor
  mesh term: Rifampin
  mesh term: Verapamil
  mesh term: Midazolam
  mesh term: Omeprazole
  mesh term: Rosuvastatin Calcium
  sharing ipd: Undecided