<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/NCT03757390</url>
  </required_header>
  <id_info>
    <org_study_id>CJ_EXR_104</org_study_id>
    <nct_id>NCT03757390</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of CJ-30060 in Healthy Volunteers</brief_title>
  <official_title>An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CJ-30060 in Healthy 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </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 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 volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 9, 2018</start_date>
  <completion_date type="Anticipated">December 14, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 14, 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>Cmax of amlodipine</measure>
    <time_frame>Up to 144 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of valsartan</measure>
    <time_frame>Up to 48 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of rosuvastatin</measure>
    <time_frame>Up to 72 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast of amlodipine</measure>
    <time_frame>Up to 144 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast of valsartan</measure>
    <time_frame>Up to 48 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast of rosuvastatin</measure>
    <time_frame>Up to 72 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCinf 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="Anticipated">52</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>period 1: receive Exforge® tab 5/160mg, Crestor® tab 10mg&#xD;
period 2: receive CJ-30060 5/160/10mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>period 1: receive CJ-30060 5/160/10mg&#xD;
period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exforge® tab 5/160mg, Crestor® tab 10mg</intervention_name>
    <description>co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-30060 5/160/10mg</intervention_name>
    <description>Fixed-dose combination drug containing Amlodipine 5mg and Valsartan 160mg and Rosuvastatin 10mg</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers aged 20 to 45 years at screening&#xD;
&#xD;
          -  BMI: 18~29.9kg/㎡&#xD;
&#xD;
          -  Body weight ≥50kg&#xD;
&#xD;
          -  Subjects who decided to participate in the study and signed informed consent form&#xD;
             voluntarily after receiving detailed explanation of the study and fully understanding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who had a medical history of severe cardiovascular, respiratory,&#xD;
             hepatobiliary, renal, hematological, gastrointestinal, endocrinological,&#xD;
             immunological, dermatological or neuropsychological disease&#xD;
&#xD;
          -  Subjects who have symptoms of an acute disease within 28days before first&#xD;
             administration&#xD;
&#xD;
          -  Subjects who have clinically significant active, chronic disease&#xD;
&#xD;
          -  Subjects who fall under the criteria below in laboratory test&#xD;
&#xD;
               -  AST/ALT &gt; UNL (upper normal limit) × 2&#xD;
&#xD;
               -  Total bilirubin &gt; UNL × 1.5&#xD;
&#xD;
               -  CrCL &lt; 50mL/min&#xD;
&#xD;
               -  CPK &gt; UNL × 2.5&#xD;
&#xD;
          -  Subjects with clinically significant low blood pressure at screening test(systolic&#xD;
             blood presure is less than 100mmHg or diastolic blood pressure is less than 60mmHg)&#xD;
&#xD;
          -  Subjects with any positive reaction in HBsAg, anti-HCV Ab, anti HIV Ab, VDRL tests&#xD;
      </textblock>
    </criteria>
    <gender>All</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>
  <overall_contact>
    <last_name>Hyo-Sook Seo</last_name>
    <phone>82-2-6477-0262</phone>
    <email>hs.seo1@cj.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Min-ja Kang</last_name>
    <phone>82-2-6477-0260</phone>
    <email>minja.kang@cj.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 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, 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/NCT03757390
org study id: CJ_EXR_104
nct id: NCT03757390
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and
      Exforge® 5/160mg, Crestor® 10mg in healthy 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 volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax of amlodipine
time frame: Up to 144 hours post-dose
measure: Cmax of valsartan
time frame: Up to 48 hours post-dose
measure: Cmax of rosuvastatin
time frame: Up to 72 hours post-dose
measure: AUClast of amlodipine
time frame: Up to 144 hours post-dose
measure: AUClast of valsartan
time frame: Up to 48 hours post-dose
measure: AUClast of rosuvastatin
time frame: Up to 72 hours post-dose
measure: AUCinf of amlodipine, valsartan, rosuvastatin
time frame: Up to 144 hours post-dose
arm group label: Sequence 1
arm group type: Experimental
description: period 1: receive Exforge® tab 5/160mg, Crestor® tab 10mg
period 2: receive CJ-30060 5/160/10mg
arm group label: Sequence 2
arm group type: Experimental
description: period 1: receive CJ-30060 5/160/10mg
period 2: receive Exforge® tab 5/160mg, Crestor® tab 10mg
intervention type: Drug
intervention name: Exforge® tab 5/160mg, Crestor® tab 10mg
description: co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg
arm group label: Sequence 1
arm group label: Sequence 2
intervention type: Drug
intervention name: CJ-30060 5/160/10mg
description: Fixed-dose combination drug containing Amlodipine 5mg and Valsartan 160mg and Rosuvastatin 10mg
arm group label: Sequence 1
arm group label: Sequence 2
criteria: 
gender: All
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
last name: Hyo-Sook Seo
phone: 82-2-6477-0262
email: hs.seo1@cj.net
last name: Min-ja Kang
phone: 82-2-6477-0260
email: minja.kang@cj.net
facility: 
status: Recruiting
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Amlodipine, Valsartan Drug Combination
mesh term: Rosuvastatin Calcium
sharing ipd: No