<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/NCT03250052</url>
  </required_header>
  <id_info>
    <org_study_id>BR-FLC-CT-101</org_study_id>
    <nct_id>NCT03250052</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers</brief_title>
  <official_title>A Phase I Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate pharmacokinetic interactions and safety between&#xD;
      fimasartan and linagliptin in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, randomized, multiple-dose, two-period and single-sequence study to&#xD;
      evaluate the pharmacokinetics and safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">November 21, 2017</completion_date>
  <primary_completion_date type="Actual">October 13, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>[Part A] AUC of fimasartan</measure>
    <time_frame>0~24 hour after drug administration</time_frame>
    <description>[Part A] Area under the curve(AUC) of fimasartan in steady state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>[Part A] Cmax of fimasartan</measure>
    <time_frame>0~24 hour after drug administration</time_frame>
    <description>[Part A] Cmax of fimasartan in steady state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>[Part B] AUC of Linagliptin</measure>
    <time_frame>0~24 hour after drug administration</time_frame>
    <description>[Part B] Area under the curve(AUC) of Linagliptin in Steady State</description>
  </primary_outcome>
  <primary_outcome>
    <measure>[Part B] Cmax of linagliptin</measure>
    <time_frame>0~24 hour after drug administration</time_frame>
    <description>[Part B] Cmax of linagliptin in steady state</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Part A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>(fimasartan or linagliptin) x 7days</intervention_name>
    <description>Part A: fimasartan, Part B: linagliptin</description>
    <arm_group_label>Part A</arm_group_label>
    <arm_group_label>Part B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>(fimasartan and linagliptin) x 7days</intervention_name>
    <description>Part A &amp; Part B: Co-administration of fimasartan and linagliptin</description>
    <arm_group_label>Part A</arm_group_label>
    <arm_group_label>Part B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Inclusion Criteria (Total: 5):&#xD;
&#xD;
          1. 19-50 year-old healthy male.&#xD;
&#xD;
          2. 18.5kg/m2 ≤ Body mass index(BMI) ≤ 27kg/m2&#xD;
&#xD;
          3. Subject who has no clinically significant medical history.&#xD;
&#xD;
          4. Subject whose informed consent is obtained and who is willing to comply with protocol.&#xD;
&#xD;
        2. Exclusion Criteria (Total: 19):&#xD;
&#xD;
          1. Sitting systolic blood pressure(SiSBP) ≥ 140mmHg or &lt; 115mmHg / Sitting Diastolic&#xD;
             blood pressure(SiDBP) ≥ 90mmHg or &lt; 70mmHg&#xD;
&#xD;
          2. Upper Limits of Normal x 1.5 &lt; Aspartate transaminase(AST), Alanine transminase(ALT),&#xD;
             Total bilirubin&#xD;
&#xD;
          3. Creatinine clearance(CrCl) &lt; 80mL/min (using Cockcroft-Gault formula)&#xD;
&#xD;
          4. Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease&#xD;
             research laboratory(VDRL)&#xD;
&#xD;
          5. Participate in another clinical trial within 12 weeks prior to the first&#xD;
             administration of Investigational product(IP).&#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>
  <overall_official>
    <last_name>Young-Ran Yoon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyungpook National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyungpook 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>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</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>
  <keyword>Fimasartan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Linagliptin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03250052
org study id: BR-FLC-CT-101
nct id: NCT03250052
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate pharmacokinetic interactions and safety between
      fimasartan and linagliptin in healthy male volunteers.
This is an open-label, randomized, multiple-dose, two-period and single-sequence study to
      evaluate the pharmacokinetics and safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: [Part A] AUC of fimasartan
time frame: 0~24 hour after drug administration
description: [Part A] Area under the curve(AUC) of fimasartan in steady state
measure: [Part A] Cmax of fimasartan
time frame: 0~24 hour after drug administration
description: [Part A] Cmax of fimasartan in steady state
measure: [Part B] AUC of Linagliptin
time frame: 0~24 hour after drug administration
description: [Part B] Area under the curve(AUC) of Linagliptin in Steady State
measure: [Part B] Cmax of linagliptin
time frame: 0~24 hour after drug administration
description: [Part B] Cmax of linagliptin in steady state
arm group label: Part A
arm group type: Experimental
description: Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days
arm group label: Part B
arm group type: Experimental
description: Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days
intervention type: Drug
intervention name: (fimasartan or linagliptin) x 7days
description: Part A: fimasartan, Part B: linagliptin
arm group label: Part A
arm group label: Part B
intervention type: Drug
intervention name: (fimasartan and linagliptin) x 7days
description: Part A & Part B: Co-administration of fimasartan and linagliptin
arm group label: Part A
arm group label: Part B
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Young-Ran Yoon, PhD
role: Principal Investigator
affiliation: Kyungpook National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Linagliptin
sharing ipd: No