<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/NCT02994745</url>
  </required_header>
  <id_info>
    <org_study_id>BR-FAVC-CT-102</org_study_id>
    <nct_id>NCT02994745</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.</brief_title>
  <official_title>A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120mg/Atorvastatin 40mg and Co-administration of Fimasartan 120mg and Atorvastatin 40mg in Healthy Male Volunteers.</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of&#xD;
      Fimasartan and Atorvastatin in Healthy Male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to&#xD;
      evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized&#xD;
      subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin&#xD;
      and co-administration of Fimasartan and Atorvastatin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 23, 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">February 21, 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(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin</measure>
    <time_frame>0~48 hours after medication</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin</measure>
    <time_frame>0~48 hours after medication</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Hypertension, Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>A fixed dose combination group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A fixed dose combination of Fimasartan/Atorvastatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Co-administration group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Co-administration of Fimasartan and Atorvastatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fimasartan, Atorvastatin</intervention_name>
    <arm_group_label>A fixed dose combination group</arm_group_label>
    <arm_group_label>Co-administration group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A Healthy male aged 19-50 years&#xD;
&#xD;
          -  Body weight is over 55kg and BMI 18 ~ 27(kg/m2).&#xD;
&#xD;
          -  A subject provide written informed consent which he voluntarily confirms willingness&#xD;
             to participate in a study, having been informed of the full details of the study and&#xD;
             comply with the protocol.&#xD;
&#xD;
          -  A subject who is eligible according to investigator's assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of clinically significant medical or psychiatric condition or&#xD;
             disease.&#xD;
&#xD;
          -  History of gastrointestinal disease and resection&#xD;
&#xD;
          -  Hypersensitivity to ingredient of investigational product(IP) and other medication,&#xD;
             food.&#xD;
&#xD;
          -  Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or&#xD;
             Glucose-galactose malabsorption.&#xD;
&#xD;
          -  A subject who take a drug that inhibit or induce significantly Drug-Metabolizing&#xD;
             Enzyme within 1months.&#xD;
&#xD;
          -  Positive results for serum examination(HIV, B and C viral test, Syphilis).&#xD;
&#xD;
          -  Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening.&#xD;
&#xD;
          -  Participation in any other study within 3months.&#xD;
&#xD;
          -  History of whole blood donation within 2months and Apheresis 2 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>January 16, 2018</last_update_submitted>
  <last_update_submitted_qc>January 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</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/NCT02994745
org study id: BR-FAVC-CT-102
nct id: NCT02994745
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of
      Fimasartan and Atorvastatin in Healthy Male volunteers.
This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to
      evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized
      subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin
      and co-administration of Fimasartan and Atorvastatin.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin
time frame: 0~48 hours after medication
measure: AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin
time frame: 0~48 hours after medication
arm group label: A fixed dose combination group
arm group type: Experimental
description: A fixed dose combination of Fimasartan/Atorvastatin
arm group label: Co-administration group
arm group type: Active Comparator
description: Co-administration of Fimasartan and Atorvastatin
intervention type: Drug
intervention name: Fimasartan, Atorvastatin
arm group label: A fixed dose combination group
arm group label: Co-administration group
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hyperlipidemias
mesh term: Atorvastatin