<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/NCT02995239</url>
  </required_header>
  <id_info>
    <org_study_id>CJ_APA_106</org_study_id>
    <nct_id>NCT02995239</nct_id>
  </id_info>
  <brief_title>A Study to Compare the Pharmacokinetic Characteristics of CJ-12420</brief_title>
  <official_title>A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of CJ-12420 in Healthy Male Volunteers</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 after administration of different formulation of CJ-12420&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare the pharmacokinetics after a single dose&#xD;
      administration of CJ-12420 formulation 1 and formulation 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 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>Assessment of the AUClast</measure>
    <time_frame>Up to 48 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the AUCinf</measure>
    <time_frame>Up to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>Up to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2</measure>
    <time_frame>Up to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd/F</measure>
    <time_frame>Up to 48 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Erosive Esophagitis</condition>
  <arm_group>
    <arm_group_label>CJ-12420 formulation 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CJ-12420 formulation 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CJ-12420 formulation 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CJ-12420 formulation 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 formulation 2</intervention_name>
    <description>CJ-12420 formulation 2</description>
    <arm_group_label>CJ-12420 formulation 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 formulation 1</intervention_name>
    <description>CJ-12420 formulation 1</description>
    <arm_group_label>CJ-12420 formulation 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male aged 19 to 45 years at the screening&#xD;
&#xD;
          -  Subject who is over 50kg with BMI between 19 kg/m2 to 28 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 fall under the criteria below in laboratory test.&#xD;
&#xD;
               -  AST, ALT, ALP, GGT, total bilirubin, BUN, creatinine &gt; UNL x 1.5&#xD;
&#xD;
          -  Subject who with low blood pressure with clinical significance at screening test.&#xD;
&#xD;
               -  (systolic blood pressure is less than 90 mmHg or over 140 mmHg, and diastolic&#xD;
                  blood pressure is less than 50 mmHg or over 90 mmHg)&#xD;
&#xD;
          -  Subject who has a medical history of symptomatic GERD, erosive esophagitis or duodenal&#xD;
             ulcer, gastric ulcer, barrett's esophagus or zollinger-ellison syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min-Gul Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk university hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Chonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>July 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</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>Esophagitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02995239
org study id: CJ_APA_106
nct id: NCT02995239
lead sponsor: 
has dmc: No
To compare the pharmacokinetics after administration of different formulation of CJ-12420
The purpose of this study is to compare the pharmacokinetics after a single dose
      administration of CJ-12420 formulation 1 and formulation 2.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of the AUClast
time frame: Up to 48 hours
measure: Assessment of the AUCinf
time frame: Up to 48 hours
measure: Tmax
time frame: Up to 48 hours
measure: t1/2
time frame: Up to 48 hours
measure: Vd/F
time frame: Up to 48 hours
arm group label: CJ-12420 formulation 1
arm group type: Active Comparator
description: CJ-12420 formulation 1
arm group label: CJ-12420 formulation 2
arm group type: Active Comparator
description: CJ-12420 formulation 2
intervention type: Drug
intervention name: CJ-12420 formulation 2
description: CJ-12420 formulation 2
arm group label: CJ-12420 formulation 1
intervention type: Drug
intervention name: CJ-12420 formulation 1
description: CJ-12420 formulation 1
arm group label: CJ-12420 formulation 2
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Min-Gul Kim, MD
role: Principal Investigator
affiliation: Chonbuk university hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Esophagitis
sharing ipd: Undecided