<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/NCT01671020</url>
  </required_header>
  <id_info>
    <org_study_id>A657-BR-CT-115</org_study_id>
    <nct_id>NCT01671020</nct_id>
  </id_info>
  <brief_title>Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects</brief_title>
  <official_title>Open-label, Randomized, Crossover Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boryung Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boryung Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and&#xD;
      single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb®&#xD;
      tablet (fimasartan) in healthy subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl,</measure>
    <time_frame>PO : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr, IV : 0.25, 0.5, 0.75, 1, 1.08, 1.17, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>(R)(T)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Period 1: Fimasartan 60mg → Period 2: Fimasartan 30mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(T)(R)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Period 1: Fimasartan 30mg → Period 2: Fimasartan 60mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fimasartan</intervention_name>
    <description>Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg</description>
    <arm_group_label>(R)(T)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fimasartan</intervention_name>
    <description>Period 1 first administration of fimasartan 30mg Period 2 second administration of fimasartan 60mg</description>
    <arm_group_label>(T)(R)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: 20 - 55 years&#xD;
&#xD;
          -  body weight: standard weight(Broca's index, Possible range is plus or minus 20percent)&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergy to Fimasartan&#xD;
&#xD;
          -  existing cardiac or hematological diseases&#xD;
&#xD;
          -  existing hepatic and renal diseases&#xD;
&#xD;
          -  existing gastrointestinal diseases&#xD;
&#xD;
          -  acute or chronic diseases which could affect drug absorption or metabolism history of&#xD;
             any serious psychological disorder&#xD;
&#xD;
          -  abnormal diet which could affect drug absorption or metabolism&#xD;
&#xD;
          -  positive drug or alcohol screening&#xD;
&#xD;
          -  smokers of 10 or more cigarettes per day&#xD;
&#xD;
          -  participation in a clinical trial during the last 90 days prior to the start of the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jae-Gook Shin, M.D, Ph.d</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Clinical Pharmacology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inje University Busan Paik Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>June 29, 2016</last_update_submitted>
  <last_update_submitted_qc>June 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fimasartan</keyword>
  <keyword>absolute bioavailability</keyword>
  <!-- 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/NCT01671020
org study id: A657-BR-CT-115
nct id: NCT01671020
lead sponsor: 
has dmc: Yes
Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and
      single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb®
      tablet (fimasartan) in healthy subjects
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl,
time frame: PO : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr, IV : 0.25, 0.5, 0.75, 1, 1.08, 1.17, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr
arm group label: (R)(T)
arm group type: Active Comparator
description: Period 1: Fimasartan 60mg → Period 2: Fimasartan 30mg
arm group label: (T)(R)
arm group type: Active Comparator
description: Period 1: Fimasartan 30mg → Period 2: Fimasartan 60mg
intervention type: Drug
intervention name: Fimasartan
description: Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg
arm group label: (R)(T)
intervention type: Drug
intervention name: Fimasartan
description: Period 1 first administration of fimasartan 30mg Period 2 second administration of fimasartan 60mg
arm group label: (T)(R)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jae-Gook Shin, M.D, Ph.d
role: Principal Investigator
affiliation: Division of Clinical Pharmacology
facility: 
country: Korea, Republic of
responsible party type: Sponsor