<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/NCT02196805</url>
  </required_header>
  <id_info>
    <org_study_id>009-09-801-01</org_study_id>
    <nct_id>NCT02196805</nct_id>
  </id_info>
  <brief_title>A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Beijing Research Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Beijing Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the pharmacokinetics characteristics of a single oral intake of an&#xD;
      imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang&#xD;
      Tai)(1*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">December 2009</completion_date>
  <primary_completion_date type="Actual">September 2009</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BE parameters: AUC0-t</measure>
    <time_frame>blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>BE parameters: Cmax</measure>
    <time_frame>blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters: Cmax</measure>
    <time_frame>blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters: Tmax</measure>
    <time_frame>blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters: AUC0-t</measure>
    <time_frame>blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters: AUC0-∞</measure>
    <time_frame>blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters: t1/2</measure>
    <time_frame>blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Chinese Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group A: imported Probucol ( Lorelco)</intervention_name>
    <description>Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O.</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group B: Marketed Probucol ( Chang Tai)</intervention_name>
    <description>Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O.</description>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese Male, aged between 18 and 40 years (at time of informed consent), extremes&#xD;
             included&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Normal weight as defined by a Quetelet body mass index range of 18.0 - 26.0 kg/m2,&#xD;
             extremes included&#xD;
&#xD;
          -  Subjects judged by the investigator or sub investigator to be healthy based on the&#xD;
             physical examination, medical history, vital signs, electrocardiogram (ECG), and the&#xD;
             results of clinical laboratory tests&#xD;
&#xD;
          -  Provided signed informed consent prior to beginning protocol-specific procedures,&#xD;
             indicating that they understood the purpose of this study&#xD;
&#xD;
          -  Willing to adhere to the study procedures described in this protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of respiratory system disease, cardiovascular disease, Renal and Urogenital&#xD;
             Disease, Gastrointestinal disease, hematological disease, Neuropsychiatric disease,&#xD;
             endocrine diseases, hepatic disease or any other disease or physical condition which&#xD;
             could have interfered with the interpretation of the study results&#xD;
&#xD;
          -  Known hypersensitivity history to any prescription drug or over-the-counter medication&#xD;
&#xD;
          -  Use of the following medications or products during the periods specified below:&#xD;
&#xD;
        Any medication within 14 days prior to scheduled study drug administration; Alcohol and&#xD;
        caffeine within 7 days prior to scheduled study drug administration; Grapefruit or&#xD;
        grapefruit products within 14 days prior to scheduled study drug administration&#xD;
&#xD;
          -  Participation in any other clinical trial within 12 weeks prior to scheduled study&#xD;
             drug administration, or intention to participate any other clinical trial during the&#xD;
             course of the study&#xD;
&#xD;
          -  Significant loss or donation of blood or plasma (200 mL) within 30 days prior to the&#xD;
             start of the study&#xD;
&#xD;
          -  Body weight &lt;50kg&#xD;
&#xD;
          -  History of drug abuse within past 5 years or positive urine drug screen results&#xD;
&#xD;
          -  Subjects who test positive in HIV,HCV antibody,HBS antigen&#xD;
&#xD;
          -  Otherwise judged by the investigator to be inappropriate for inclusion in the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Pei Hu, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Pharmacology Research Center Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Pharmacology Research Center Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 25, 2009</study_first_submitted>
  <study_first_submitted_qc>July 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 20, 2014</last_update_submitted>
  <last_update_submitted_qc>July 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <name_title>Patiman Juma</name_title>
    <organization>Otsuka Beijing Research Institute</organization>
  </responsible_party>
  <keyword>bioequivalence</keyword>
  <keyword>imported PROBUCOL table</keyword>
  <keyword>Lorelco</keyword>
  <keyword>marketed PROBUCOL tablet</keyword>
  <keyword>Chang Tai</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Probucol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02196805
org study id: 009-09-801-01
nct id: NCT02196805
lead sponsor: 
has dmc: No
This study compares the pharmacokinetics characteristics of a single oral intake of an
      imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang
      Tai)(1*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: BE parameters: AUC0-t
time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
measure: BE parameters: Cmax
time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
measure: Pharmacokinetic Parameters: Cmax
time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration.
measure: Pharmacokinetic Parameters: Tmax
time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
measure: Pharmacokinetic Parameters: AUC0-t
time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
measure: Pharmacokinetic Parameters: AUC0-∞
time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
measure: Pharmacokinetic Parameters: t1/2
time frame: blood sample will be collected at 4,8,12,16,24,36,48,72,96,144,216,288,360,456,552,648 hour of drug administration
arm group label: 1
arm group type: Experimental
arm group label: 2
arm group type: Experimental
intervention type: Drug
intervention name: Group A: imported Probucol ( Lorelco)
description: Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O.
arm group label: 1
intervention type: Drug
intervention name: Group B: Marketed Probucol ( Chang Tai)
description: Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O.
arm group label: 2
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pei Hu, Dr.
role: Principal Investigator
affiliation: Clinical Pharmacology Research Center Peking Union Medical College Hospital
facility: 
country: China
name title: Patiman Juma
organization: Otsuka Beijing Research Institute
mesh term: Probucol