<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/NCT03247140</url>
  </required_header>
  <id_info>
    <org_study_id>JLP-1401-101-PK</org_study_id>
    <nct_id>NCT03247140</nct_id>
  </id_info>
  <brief_title>The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers</brief_title>
  <official_title>An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Coadministration of Rosuvastatin and Telmisartan/Amlodipine in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeil Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jeil 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 PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine&#xD;
      and JLP-1401 in Healthy Male Volunteers Volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2017</start_date>
  <completion_date type="Actual">November 27, 2017</completion_date>
  <primary_completion_date type="Actual">August 7, 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>AUC</measure>
    <time_frame>72hr after baseline</time_frame>
    <description>Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>72 after baseline</time_frame>
    <description>Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hypertension With Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>Group I (JLP-1401)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JLP-1401(Telmisartan 80 mg, amlodipine 10 mg, rosuvastatin 20 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II(Telmisartan/Amlodipine, Rosuvastatin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twinsta(Telmisartan 40 mg, amlodipine 5 mg) 2 tab and Crestor(rosuvastatin 20 mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JLP-1401</intervention_name>
    <description>Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)</description>
    <arm_group_label>Group I (JLP-1401)</arm_group_label>
    <arm_group_label>Group II(Telmisartan/Amlodipine, Rosuvastatin)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan/Amlodipine, Rosuvastatin</intervention_name>
    <description>Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)</description>
    <arm_group_label>Group I (JLP-1401)</arm_group_label>
    <arm_group_label>Group II(Telmisartan/Amlodipine, Rosuvastatin)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of&#xD;
             Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2&#xD;
&#xD;
          -  Subject who has the ability to comprehend the study objectives, contents and the&#xD;
             property of the study drug before participating in the trial&#xD;
&#xD;
          -  Subject who has the ability and willingness to participate the whole period of trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of medical history or a concurrent disease that may interfere with treatment&#xD;
             and safety assessment or completion of this clinical study, including clinically&#xD;
             significant disorders in kidney, liver, cardiovascular system, respiratory system,&#xD;
             endocrine system, or neuropsychiatric system.&#xD;
&#xD;
          -  Subjects who are allergic to investigational drug.&#xD;
&#xD;
          -  Subjects who have a medical history which can affect the clinical trial.&#xD;
&#xD;
          -  Systolic BP &gt; 140mmHG or Diastolic BP &gt; 90mmHg)&#xD;
&#xD;
          -  AST or ALT &gt; X 2 UNL&#xD;
&#xD;
          -  History of drug abuse or positive drug screening.&#xD;
&#xD;
          -  Participation in other drug studies within 3 months prior to the drug administration.&#xD;
&#xD;
          -  Whole blood donation within 60 days, blood component donation within 30 days or who&#xD;
             got transfusion within 30days.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Gul Kim, MD., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>December 21, 2017</last_update_submitted>
  <last_update_submitted_qc>December 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 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>Dyslipidemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Telmisartan</mesh_term>
    <mesh_term>Telmisartan amlodipine combination</mesh_term>
    <mesh_term>Rosuvastatin Calcium</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/NCT03247140
org study id: JLP-1401-101-PK
nct id: NCT03247140
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine
      and JLP-1401 in Healthy Male Volunteers Volunteers
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC
time frame: 72hr after baseline
description: Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
measure: Cmax
time frame: 72 after baseline
description: Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
arm group label: Group I (JLP-1401)
arm group type: Experimental
description: JLP-1401(Telmisartan 80 mg, amlodipine 10 mg, rosuvastatin 20 mg)
arm group label: Group II(Telmisartan/Amlodipine, Rosuvastatin)
arm group type: Experimental
description: Twinsta(Telmisartan 40 mg, amlodipine 5 mg) 2 tab and Crestor(rosuvastatin 20 mg)
intervention type: Drug
intervention name: JLP-1401
description: Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)
arm group label: Group I (JLP-1401)
arm group label: Group II(Telmisartan/Amlodipine, Rosuvastatin)
intervention type: Drug
intervention name: Telmisartan/Amlodipine, Rosuvastatin
description: Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)
arm group label: Group I (JLP-1401)
arm group label: Group II(Telmisartan/Amlodipine, Rosuvastatin)
criteria: 
gender: Male
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Min Gul Kim, MD., Ph.D
role: Principal Investigator
affiliation: Chonbuk National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dyslipidemias
mesh term: Amlodipine
mesh term: Telmisartan
mesh term: Telmisartan amlodipine combination
mesh term: Rosuvastatin Calcium
sharing ipd: No