<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/NCT02995720</url>
  </required_header>
  <id_info>
    <org_study_id>BR-FARC-CT-103</org_study_id>
    <nct_id>NCT02995720</nct_id>
  </id_info>
  <brief_title>A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin</brief_title>
  <official_title>An Open-label, Randomized, Single-dose, 2X3X3 Partial Replicate, Crossover Study to Compare the Pharmacokinetics and Safety Between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male 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>
  <brief_summary>
    <textblock>
      An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare&#xD;
      the pharmacokinetics and safety between a fixed dose combination of&#xD;
      Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of&#xD;
      Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 26, 2016</start_date>
  <completion_date type="Actual">May 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 10, 2016</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, Amlodipine and Rosuvastatin</measure>
    <time_frame>0~72 hour after medication</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin</measure>
    <time_frame>0~72 hour 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>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fimasartan/Amlodipine combination drug, Rosuvastatin</intervention_name>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subject, aged 19- 50 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically significant hypersensitivity to study drug, any other drug&#xD;
&#xD;
          -  Hypotension or hypertension&#xD;
&#xD;
          -  Active liver disease&#xD;
&#xD;
          -  History of gastrointestinal disease&#xD;
&#xD;
          -  History of excessive alcohol abuse&#xD;
&#xD;
          -  Participation in any other study within 3 months&#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>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</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>Amlodipine</mesh_term>
    <mesh_term>Rosuvastatin Calcium</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/NCT02995720
org study id: BR-FARC-CT-103
nct id: NCT02995720
lead sponsor: 
An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare
      the pharmacokinetics and safety between a fixed dose combination of
      Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of
      Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin
time frame: 0~72 hour after medication
measure: AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin
time frame: 0~72 hour after medication
arm group label: 1
arm group type: Experimental
description: A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin
arm group label: 2
arm group type: Active Comparator
description: Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin
intervention type: Drug
intervention name: Fimasartan/Amlodipine combination drug, Rosuvastatin
arm group label: 1
arm group label: 2
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Hyperlipidemias
mesh term: Amlodipine
mesh term: Rosuvastatin Calcium