<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/NCT03753477</url>
  </required_header>
  <id_info>
    <org_study_id>DW_DWJ1351004</org_study_id>
    <nct_id>NCT03753477</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Investigate the Efficacy and Safety of DWJ1351</brief_title>
  <official_title>An Open-label, Randomized, 2X2 Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1351 and Co-administration of Amlodipine/Olmesartan and Rosuvastatin in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daewoong Pharmaceutical Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daewoong Pharmaceutical Co. LTD.</source>
  <oversight_info>
    <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 compare the safety and pharmacokinetic characteristics of&#xD;
      combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare the safety and pharmacokinetic characteristics of&#xD;
      combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male&#xD;
      volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2017</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 26, 2018</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>AUC</measure>
    <time_frame>[ Time Frame: 0 - 72 hours ]</time_frame>
    <description>AUC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>[ Time Frame: 0 - 72 hours ]</time_frame>
    <description>Cmax</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCinf</measure>
    <time_frame>[ Time Frame: 0 - 72 hours ]</time_frame>
    <description>AUCinf</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>[ Time Frame: 0 - 72 hours ]</time_frame>
    <description>Tmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2β</measure>
    <time_frame>[ Time Frame: 0 - 72 hours ]</time_frame>
    <description>t1/2β</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F</measure>
    <time_frame>[ Time Frame: 0 - 72 hours ]</time_frame>
    <description>CL/F</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vdss/F</measure>
    <time_frame>[ Time Frame: 0 - 72 hours ]</time_frame>
    <description>Vdss/F</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Test Drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Drug</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sevikar and Crestor</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)</intervention_name>
    <description>DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) X 1 tablet followed by Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet (after washout period)</description>
    <arm_group_label>Test Drug</arm_group_label>
    <other_name>DWJ1351</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevikar and Crestor</intervention_name>
    <description>Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period)</description>
    <arm_group_label>Reference Drug</arm_group_label>
    <other_name>Amlodipine/Olmesartan and Rosuvastatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject who provided written informed consent to participate in this study&#xD;
&#xD;
          -  Healthy adult male subjects aged 19 to 50 years&#xD;
&#xD;
          -  Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0&#xD;
             kg/m2&#xD;
&#xD;
          -  Subject who was judged to be healthy and suitable for the participation by the&#xD;
             investigator based on screening test results&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan,&#xD;
             rosuvastatin or related drugs&#xD;
&#xD;
          -  Subjects who had a serious clinical illness that can impact fate of drugs absorption&#xD;
&#xD;
          -  Subject who shows vital signs with the number of systolic blood pressure of &gt;140 mmHg&#xD;
             or &lt;100 mmHg, and the number of diastolic blood pressure of &gt;90mmHg or &lt;65mmHg&#xD;
&#xD;
          -  Subject who have experienced drug abuse&#xD;
&#xD;
          -  Subject who donates his blood (whole blood donation within last 2 months or plasma&#xD;
             donation within last 1 month)&#xD;
&#xD;
          -  Subject who has taken other clinical or licensed medication from another clinical&#xD;
             trial within an 3-month period prior to the first administration of the study&#xD;
             medication&#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>JG Shin, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Busan Paik Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>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>November 2018</verification_date>
  <study_first_submitted>February 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Olmesartan</mesh_term>
    <mesh_term>Olmesartan Medoxomil</mesh_term>
    <mesh_term>Amlodipine Besylate, Olmesartan Medoxomil Drug Combination</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/NCT03753477
org study id: DW_DWJ1351004
nct id: NCT03753477
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the safety and pharmacokinetic characteristics of
      combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers
The purpose of this study is to compare the safety and pharmacokinetic characteristics of
      combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male
      volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC
time frame: [ Time Frame: 0 - 72 hours ]
description: AUC
measure: Cmax
time frame: [ Time Frame: 0 - 72 hours ]
description: Cmax
measure: AUCinf
time frame: [ Time Frame: 0 - 72 hours ]
description: AUCinf
measure: Tmax
time frame: [ Time Frame: 0 - 72 hours ]
description: Tmax
measure: t1/2β
time frame: [ Time Frame: 0 - 72 hours ]
description: t1/2β
measure: CL/F
time frame: [ Time Frame: 0 - 72 hours ]
description: CL/F
measure: Vdss/F
time frame: [ Time Frame: 0 - 72 hours ]
description: Vdss/F
arm group label: Test Drug
arm group type: Experimental
description: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
arm group label: Reference Drug
arm group type: Active Comparator
description: Sevikar and Crestor
intervention type: Drug
intervention name: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
description: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) X 1 tablet followed by Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet (after washout period)
arm group label: Test Drug
other name: DWJ1351
intervention type: Drug
intervention name: Sevikar and Crestor
description: Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period)
arm group label: Reference Drug
other name: Amlodipine/Olmesartan and Rosuvastatin
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: JG Shin, Ph.D
role: Principal Investigator
affiliation: Busan Paik Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Amlodipine
mesh term: Olmesartan
mesh term: Olmesartan Medoxomil
mesh term: Amlodipine Besylate, Olmesartan Medoxomil Drug Combination
mesh term: Rosuvastatin Calcium