<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/NCT03009474</url>
  </required_header>
  <id_info>
    <org_study_id>CJ_EXR_102</org_study_id>
    <nct_id>NCT03009474</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers</brief_title>
  <official_title>Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HK inno.N Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HK inno.N Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and&#xD;
      Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare the pharmacokinetics and safety after a single dose&#xD;
      administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin</measure>
    <time_frame>Up to 144 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin</measure>
    <time_frame>Up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin</measure>
    <time_frame>Up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half life (t1/2) of amlodipine, valsartan, rosuvastatin</measure>
    <time_frame>Up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin</measure>
    <time_frame>Up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin</measure>
    <time_frame>Up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Hypertension</condition>
  <condition>Hyperlipidemias</condition>
  <arm_group>
    <arm_group_label>CJ-30060</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exforge tab 5/160mg, Crestor tab 10mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-30060</intervention_name>
    <description>Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg</description>
    <arm_group_label>Exforge tab 5/160mg, Crestor tab 10mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exforge tab 5/160mg, Crestor tab 10mg</intervention_name>
    <description>Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg</description>
    <arm_group_label>CJ-30060</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male aged 20 to 45 years at the screening&#xD;
&#xD;
          -  Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)&#xD;
&#xD;
          -  Subject who fully understood after being informed detailed description of clinical&#xD;
             trial, written informed consent voluntarily to observe the precautions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who has a medical history of severe cardiovascular, respiratory,&#xD;
             hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological,&#xD;
             immunologic, dermatosis or neuropsychologic disease.&#xD;
&#xD;
          -  Subject who have symptoms, result from acute disease within 28days before first&#xD;
             administration.&#xD;
&#xD;
          -  Subject who have chronic persisting disease with clinical significance.&#xD;
&#xD;
          -  Subject who fall under the criteria below in laboratory test.&#xD;
&#xD;
               -  AST/ALT &gt; UNL (upper normal limit) x 2&#xD;
&#xD;
               -  Total bilirubin &gt; UNL x 1.5&#xD;
&#xD;
               -  In case of renal failure that creatine clearance is less than 50mL/min according&#xD;
                  to Cockcroft-Gault&#xD;
&#xD;
               -  CPK &gt; UNL x 2.5&#xD;
&#xD;
          -  Subject who with low blood pressure with clinical significance at screening test.&#xD;
&#xD;
        (systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60&#xD;
        mmHg)&#xD;
&#xD;
          -  Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ji Young Park, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Anam Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea University Anam 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 2017</verification_date>
  <study_first_submitted>March 11, 2015</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 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, Valsartan Drug 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/NCT03009474
org study id: CJ_EXR_102
nct id: NCT03009474
lead sponsor: 
has dmc: No
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and
      Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
The purpose of this study is to compare the pharmacokinetics and safety after a single dose
      administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin
time frame: Up to 144 hours post-dose
measure: Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin
time frame: Up to 144 hours post-dose
measure: Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin
time frame: Up to 144 hours post-dose
measure: Half life (t1/2) of amlodipine, valsartan, rosuvastatin
time frame: Up to 144 hours post-dose
measure: Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin
time frame: Up to 144 hours post-dose
measure: Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin
time frame: Up to 144 hours post-dose
arm group label: CJ-30060
arm group type: Experimental
description: Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
arm group label: Exforge tab 5/160mg, Crestor tab 10mg
arm group type: Active Comparator
description: Amlodipine 5 mg/ Valsartan 160 mg/ Rosuvastatin 10 mg
intervention type: Drug
intervention name: CJ-30060
description: Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg
arm group label: Exforge tab 5/160mg, Crestor tab 10mg
intervention type: Drug
intervention name: Exforge tab 5/160mg, Crestor tab 10mg
description: Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg
arm group label: CJ-30060
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ji Young Park, PhD
role: Principal Investigator
affiliation: Korea University Anam Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hyperlipidemias
mesh term: Amlodipine, Valsartan Drug Combination
mesh term: Rosuvastatin Calcium
sharing ipd: No