<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/NCT04424381</url>
  </required_header>
  <id_info>
    <org_study_id>QL-YK4-012-001</org_study_id>
    <nct_id>NCT04424381</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers</brief_title>
  <official_title>Pharmacokinetics and Bioequivalence of Generic and Branded Rivaroxaban Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Affiliated Hospital of Qingdao University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Affiliated Hospital of Qingdao University</source>
  <oversight_info>
    <has_dmc>Yes</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 study was designed as a single-site, randomized, open-label, four-period complete and&#xD;
      replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and&#xD;
      Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a&#xD;
      fasting state and 36 receiving a high-fat diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects were randomized into two treatment sequence groups: Sequence 1 = TRTR and Sequence 2&#xD;
      = RTRT, and each study period was separated by a 7 days washout period. After an overnight&#xD;
      fast for at least 10 h, the subjects received a single oral dose of the R or T formulation of&#xD;
      rivaroxaban tablets (20 mg) with 240 mL of water in a seated position. A total of 19 blood&#xD;
      samples were collected at 0 (within 60 min prior to dosing) and 0.25,0.5, 1.0, 1.5, 2.0,&#xD;
      2.5,3.0,3.5, 4.0, 4.5,5.0, 5.5,6.0, 8.0, 12.0, 24.0, 36.0 ,and 48.0 hours after dosing.Blood&#xD;
      samples were collected in a vacuum blood tube containing sodium heparin, gently mixed, and&#xD;
      stored on ice-water mixture until sample processing and then centrifuged at 2000g at 2-8°C&#xD;
      for 10 min.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2019</start_date>
  <completion_date type="Actual">September 20, 2019</completion_date>
  <primary_completion_date type="Actual">September 5, 2019</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>
    <intervention_model_description>The study was designed as a four-period complete and replicate crossover</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>94 days</time_frame>
    <description>Evaluation of Peak Plasma Concentration (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)0-t</measure>
    <time_frame>94 days</time_frame>
    <description>Evaluation of Area under the plasma concentration versus time curve (AUC)0-t</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)0-∞</measure>
    <time_frame>94 days</time_frame>
    <description>Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>94 days</time_frame>
    <description>Collection of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal blood pressure</measure>
    <time_frame>94 days</time_frame>
    <description>Monitor the blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal temperature</measure>
    <time_frame>94 days</time_frame>
    <description>Monitor the temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal pulse</measure>
    <time_frame>94 days</time_frame>
    <description>Monitor the pulse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal electrocardiogram waveform</measure>
    <time_frame>94 days</time_frame>
    <description>Electrocardiogram inspection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Rivaroxaban 20 MG Oral Tablet [Xarelto]</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>rivaroxaban oral tablet [Xarelto] at a single oral dose of 20 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rivaroxaban 20 MG Oral Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rivaroxaban oral tablet at a single oral dose of 20 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban 20 MG Oral Tablet [Xarelto]</intervention_name>
    <description>The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet [Xarelto].</description>
    <arm_group_label>Rivaroxaban 20 MG Oral Tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivaroxaban 20 MG Oral Tablet</intervention_name>
    <description>The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.</description>
    <arm_group_label>Rivaroxaban 20 MG Oral Tablet [Xarelto]</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female aged 18 and above.&#xD;
&#xD;
          -  The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value).&#xD;
             The weight of male is not less than 50.0 kg, and that of female is not less than 45.0&#xD;
             kg.&#xD;
&#xD;
          -  The following examination show that the indicators are normal or abnormal without&#xD;
             clinical significance. The examination including: Vital signs, physical examination,&#xD;
             blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological&#xD;
             tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV),&#xD;
             and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.&#xD;
&#xD;
          -  The subjects have no family planning within 3 months and could select contraceptive&#xD;
             method.Before the study, all subjects&#xD;
&#xD;
          -  Before the study, all subjects have been informed of the study's purpose, protocal,&#xD;
             benefits, and risks, and signed the informed consent voluntarily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being allergy to the study medications, smoking, alcohol abuse.&#xD;
&#xD;
          -  Participation in another clinical trial within 3 months.&#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>yu Cao</last_name>
    <role>Principal Investigator</role>
    <affiliation>the study director of phase I clinical research center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phase I Clinical Research Center</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rivaroxaban</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>bioequivalence</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All the technical achievements and outcomes of this trial are owned by Qilu Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor</ipd_description>
  </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/NCT04424381
org study id: QL-YK4-012-001
nct id: NCT04424381
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study was designed as a single-site, randomized, open-label, four-period complete and
      replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and
      Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a
      fasting state and 36 receiving a high-fat diet.
Subjects were randomized into two treatment sequence groups: Sequence 1 = TRTR and Sequence 2
      = RTRT, and each study period was separated by a 7 days washout period. After an overnight
      fast for at least 10 h, the subjects received a single oral dose of the R or T formulation of
      rivaroxaban tablets (20 mg) with 240 mL of water in a seated position. A total of 19 blood
      samples were collected at 0 (within 60 min prior to dosing) and 0.25,0.5, 1.0, 1.5, 2.0,
      2.5,3.0,3.5, 4.0, 4.5,5.0, 5.5,6.0, 8.0, 12.0, 24.0, 36.0 ,and 48.0 hours after dosing.Blood
      samples were collected in a vacuum blood tube containing sodium heparin, gently mixed, and
      stored on ice-water mixture until sample processing and then centrifuged at 2000g at 2-8°C
      for 10 min.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The study was designed as a four-period complete and replicate crossover
primary purpose: Treatment
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax)
time frame: 94 days
description: Evaluation of Peak Plasma Concentration (Cmax)
measure: Area under the plasma concentration versus time curve (AUC)0-t
time frame: 94 days
description: Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
measure: Area under the plasma concentration versus time curve (AUC)0-∞
time frame: 94 days
description: Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 94 days
description: Collection of adverse events
measure: Incidence of abnormal blood pressure
time frame: 94 days
description: Monitor the blood pressure
measure: Incidence of abnormal temperature
time frame: 94 days
description: Monitor the temperature
measure: Incidence of abnormal pulse
time frame: 94 days
description: Monitor the pulse
measure: Incidence of abnormal electrocardiogram waveform
time frame: 94 days
description: Electrocardiogram inspection
arm group label: Rivaroxaban 20 MG Oral Tablet [Xarelto]
arm group type: Active Comparator
description: rivaroxaban oral tablet [Xarelto] at a single oral dose of 20 mg
arm group label: Rivaroxaban 20 MG Oral Tablet
arm group type: Experimental
description: rivaroxaban oral tablet at a single oral dose of 20 mg
intervention type: Drug
intervention name: Rivaroxaban 20 MG Oral Tablet [Xarelto]
description: The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet [Xarelto].
arm group label: Rivaroxaban 20 MG Oral Tablet
intervention type: Drug
intervention name: Rivaroxaban 20 MG Oral Tablet
description: The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.
arm group label: Rivaroxaban 20 MG Oral Tablet [Xarelto]
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: yu Cao
role: Principal Investigator
affiliation: the study director of phase I clinical research center
facility: 
country: China
responsible party type: Sponsor
mesh term: Rivaroxaban
sharing ipd: No
ipd description: All the technical achievements and outcomes of this trial are owned by Qilu Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor