<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/NCT03302182</url>
  </required_header>
  <id_info>
    <org_study_id>ZYYY-LTNW-BE-2017-05-2</org_study_id>
    <nct_id>NCT03302182</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects</brief_title>
  <acronym>RTV</acronym>
  <official_title>An Open-label, Randomized Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ascletis Pharmaceuticals 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>
      The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir&#xD;
      tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting&#xD;
      or fed condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence&#xD;
      Study with a washout period of 6 days. During each session, the subjects will be administered&#xD;
      a single dose of 100mg Ritonavir (one Ritonavir Tablet 100mg or one NORVIR Tablet 100mg)&#xD;
      under fasting or fed condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2017</start_date>
  <completion_date type="Actual">December 4, 2017</completion_date>
  <primary_completion_date type="Actual">November 4, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>36 hours post-dose on Day 1,7</time_frame>
    <description>Maximum Observed Plasma Concentration for ritonavir&#xD;
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>36 hours post-dose on Day 1,7</time_frame>
    <description>Time to Reach the Maximum Plasma Concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf)</measure>
    <time_frame>Time Frame: 36 hours post-dose on Day 1,7</time_frame>
    <description>Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-36h)</measure>
    <time_frame>36 hours post-dose on Day 1,7</time_frame>
    <description>Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>fasting group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fasting condition.&#xD;
For group1:&#xD;
cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg&#xD;
For group2:&#xD;
cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fed group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fed condition.&#xD;
For group3:&#xD;
cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg&#xD;
For group4:&#xD;
cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir for cycle1 and NORVIR for cycle 2</intervention_name>
    <description>During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .</description>
    <arm_group_label>Fed group</arm_group_label>
    <arm_group_label>fasting group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NORVIR for cycle 1 and Ritonavir for cycle 2</intervention_name>
    <description>During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .</description>
    <arm_group_label>Fed group</arm_group_label>
    <arm_group_label>fasting group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult volunteers of 18-45 years old.&#xD;
&#xD;
          2. Male (weight ≥50kg);Female (weight ≥45kg)&#xD;
&#xD;
          3. Body mass index (BMI) between 19~28 kg/m2;&#xD;
&#xD;
          4. In good health as determined by a physician/investigator based on medical history,&#xD;
             vital signs, electrocardiogram (ECG), laboratory tests and physical examination&#xD;
             findings at screening;&#xD;
&#xD;
          5. Female participant with negative result of HCG test and agrees to use adequate&#xD;
             contraception from signing of informed consent form throughout the duration of the&#xD;
             study and for 6 months after the last dose of study drug;&#xD;
&#xD;
          6. Male participant agrees to use adequate contraception and have no plan to donate sperm&#xD;
             from signing of informed consent form throughout the duration of the study and for 6&#xD;
             months after the last dose of study drug;&#xD;
&#xD;
          7. Subject who totally understand the aim and progress of this clinical trial, make&#xD;
             decision by his/her free will, and signed a consent form to follow the progress;&#xD;
&#xD;
          8. In the opinion of the investigator, the participant is capable of understanding and&#xD;
             complying with protocol requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject who cannot tolerate venipuncture.&#xD;
&#xD;
          2. Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the&#xD;
             trial as judged by the investigator;&#xD;
&#xD;
          3. Subject who has past or present history of any serious diseases, including (but not&#xD;
             limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal,&#xD;
             endocrine, psychiatric or neurological, hematologic, immunological or metabolic&#xD;
             disorders;&#xD;
&#xD;
          4. Abnormal results of physical examination (hematology, urine test,blood biochemistry&#xD;
             etc.), vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) or x-ray&#xD;
             with clinical significance.&#xD;
&#xD;
          5. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV)&#xD;
             antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test;&#xD;
&#xD;
          6. Women who is during lactation, pregnancy or plan to have baby recently.&#xD;
&#xD;
          7. Women with positive result of HCG test.&#xD;
&#xD;
          8. Subject who refuse to use adequate contraception from signing of informed consent form&#xD;
             throughout the duration of the study and for 6 months after the last dose of study&#xD;
             drug;&#xD;
&#xD;
          9. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol&#xD;
             abuse (defined as alcohol consumption exceeding 14 units per week) within 6 months&#xD;
             preceding this study or is unwilling to agree to abstain from alcohol and drugs&#xD;
             throughout the study;&#xD;
&#xD;
         10. Heavy smokers (&gt;5 cigarettes per day) within 6 months preceding this study or is&#xD;
             unwilling to agree to abstain from smoking throughout the study;&#xD;
&#xD;
         11. Positive test results for alcohol or drug at Screening;&#xD;
&#xD;
         12. History of hospitalization or surgery within 3 months preceding this study.&#xD;
&#xD;
         13. Blood donation within the last 2 months (&gt;= 400 ml), or have a plan to donate blood&#xD;
             within 1 month after this study;&#xD;
&#xD;
         14. Intake of any other drug which might influence the results of the trial during two&#xD;
             weeks previous to the start of the study.&#xD;
&#xD;
         15. Participation in another study with an investigational drug within the last 3 months&#xD;
             preceding this study;&#xD;
&#xD;
         16. History of gastrointestinal surgery, vagotomy, enterotomy or other surgery that may&#xD;
             influence gastrointestinal motility,PH or gastrointestinal absorption.&#xD;
&#xD;
         17. Intake of grapefruit or orange (or other food containing grapefruit or orange) 3 days&#xD;
             previous to the start of the study. Intake of tea,coffee or other drink containing&#xD;
             coffee more than 1L per day.&#xD;
&#xD;
         18. Consideration by the investigator, for any reason, that the subject is an unsuitable&#xD;
             candidate to receive Ritonavir.&#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>
  <location>
    <facility>
      <name>First affiliated hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2018</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>Ritonavir</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/NCT03302182
org study id: ZYYY-LTNW-BE-2017-05-2
nct id: NCT03302182
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir
      tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting
      or fed condition.
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence
      Study with a washout period of 6 days. During each session, the subjects will be administered
      a single dose of 100mg Ritonavir (one Ritonavir Tablet 100mg or one NORVIR Tablet 100mg)
      under fasting or fed condition.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax
time frame: 36 hours post-dose on Day 1,7
description: Maximum Observed Plasma Concentration for ritonavir
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
measure: Tmax
time frame: 36 hours post-dose on Day 1,7
description: Time to Reach the Maximum Plasma Concentration
measure: AUC(0-inf)
time frame: Time Frame: 36 hours post-dose on Day 1,7
description: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir
measure: AUC(0-36h)
time frame: 36 hours post-dose on Day 1,7
description: Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir
arm group label: fasting group
arm group type: Experimental
description: During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fasting condition.
For group1:
cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg
For group2:
cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg
arm group label: Fed group
arm group type: Experimental
description: During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fed condition.
For group3:
cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg
For group4:
cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg
intervention type: Drug
intervention name: Ritonavir for cycle1 and NORVIR for cycle 2
description: During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .
arm group label: Fed group
arm group label: fasting group
intervention type: Drug
intervention name: NORVIR for cycle 1 and Ritonavir for cycle 2
description: During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .
arm group label: Fed group
arm group label: fasting group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Ritonavir
sharing ipd: No