<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/NCT02185066</url>
  </required_header>
  <id_info>
    <org_study_id>CJ_ATM_103</org_study_id>
    <nct_id>NCT02185066</nct_id>
  </id_info>
  <brief_title>Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR</brief_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>
      This study is designed to evaluate safety and pharmacokinetic properties of the two&#xD;
      treatments, the administration of CJ-30056 and the co-administration of atorvastatin and&#xD;
      metformin XR, in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Maximum plasma concentration (Cmax) of Atorvastatin</measure>
    <time_frame>Upto 36 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax) of Metformin</measure>
    <time_frame>Upto 24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin</measure>
    <time_frame>Upto 36 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the plasma concentration-time Curve (AUC0-t) of Metformin</measure>
    <time_frame>Upto 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax) of 2-OH-atorvastatin</measure>
    <time_frame>Upto 36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin</measure>
    <time_frame>Upto 36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of Atorvastatin and Metformin</measure>
    <time_frame>Upto 36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd/F of Atorvastatin and Metformin</measure>
    <time_frame>Upto 36 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-dose crossover&#xD;
Reference: Atorvastatin 20mg and Metformin XR 500mg&#xD;
Test: CJ-30056 20/500mg&#xD;
Once daily Oral administration with 7days of washout period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-dose crossover&#xD;
Test: CJ-30056 20/500mg&#xD;
Reference: Atorvastatin 20mg and Metformin XR 500mg&#xD;
Once daily Oral administration with 7days of washout period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin 20mg and Metformin XR 500mg (Reference)</intervention_name>
    <description>Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.&#xD;
Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-30056 20/500mg (Test)</intervention_name>
    <description>Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.&#xD;
Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willing to adhere to protocol requirements and sign a informed consent form&#xD;
&#xD;
          2. Male volunteers in the age between 19 and 55 years old and have the weight range is&#xD;
             not exceed ±20% of ideal weight&#xD;
&#xD;
          3. Subjects with no history of any significant chronic disease&#xD;
&#xD;
          4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and&#xD;
             routine laboratory data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of barbital inducer or inhibitor medication within the 4 weeks before dosing&#xD;
&#xD;
          2. Symptom of an acute illness within 4 weeks prior to drug administration&#xD;
&#xD;
          3. History of clinically significant hepatic, renal, gastrointestinal diseases which&#xD;
             might significantly interfere with ADME&#xD;
&#xD;
          4. History of surgery except or gastrointestinal diseases which might significantly&#xD;
             change absorption of medicines&#xD;
&#xD;
          5. History of clinically significant allergies including drug allergies&#xD;
&#xD;
          6. History of clinically significant allergies about atorvastatin or metformin&#xD;
&#xD;
          7. Subjects who have ever or have plan to do intravenous injection of contrast medium&#xD;
             (intravenous urography, intravenous cholangiography, computed tomography using&#xD;
             contrast medium) within 28 days prior to drug administration&#xD;
&#xD;
          8. History of myopathy&#xD;
&#xD;
          9. Clinical laboratory test values are outside the accepted normal range&#xD;
&#xD;
               -  AST or ALT &gt;1.25 times to normal range&#xD;
&#xD;
               -  Total bilirubin &gt;1.5 times to normal range&#xD;
&#xD;
               -  e-GFR &lt;90 mL/min&#xD;
&#xD;
         10. History of drug, caffein(caffein &gt; 5 cups/day), smoking (cigarette &gt; 10/day) or&#xD;
             alcohol abuse(alcohol &gt; 30 g/day)or Subjects who have ever drink within 7 days prior&#xD;
             to drug administration&#xD;
&#xD;
         11. Special diet known to interfere with the absorption, distribution, metabolism or&#xD;
             excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior&#xD;
             to drug administration&#xD;
&#xD;
         12. Donated blood within 60 days prior to dosing&#xD;
&#xD;
         13. Participated in a previous clinical trial within 60 days prior to dosing&#xD;
&#xD;
         14. Use of any other medication, including herbal products, within 10 days before dosing&#xD;
&#xD;
         15. Subjects considered as unsuitable based on medical judgement by investigators&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong-lyul Ghim, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inje University 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>December 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</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>Metformin</mesh_term>
    <mesh_term>Atorvastatin</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/NCT02185066
org study id: CJ_ATM_103
nct id: NCT02185066
lead sponsor: 
has dmc: No
This study is designed to evaluate safety and pharmacokinetic properties of the two
      treatments, the administration of CJ-30056 and the co-administration of atorvastatin and
      metformin XR, in healthy volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum plasma concentration (Cmax) of Atorvastatin
time frame: Upto 36 hours
measure: Maximum plasma concentration (Cmax) of Metformin
time frame: Upto 24 hours
measure: Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin
time frame: Upto 36 hours
measure: Area Under the plasma concentration-time Curve (AUC0-t) of Metformin
time frame: Upto 24 hours
measure: Maximum plasma concentration (Cmax) of 2-OH-atorvastatin
time frame: Upto 36 hours
measure: Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin
time frame: Upto 36 hours
measure: CL/F of Atorvastatin and Metformin
time frame: Upto 36 hours
measure: Vd/F of Atorvastatin and Metformin
time frame: Upto 36 hours
arm group label: Group 1
arm group type: Experimental
description: Single-dose crossover
Reference: Atorvastatin 20mg and Metformin XR 500mg
Test: CJ-30056 20/500mg
Once daily Oral administration with 7days of washout period
arm group label: Group 2
arm group type: Experimental
description: Single-dose crossover
Test: CJ-30056 20/500mg
Reference: Atorvastatin 20mg and Metformin XR 500mg
Once daily Oral administration with 7days of washout period
intervention type: Drug
intervention name: Atorvastatin 20mg and Metformin XR 500mg (Reference)
description: Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.
Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.
arm group label: Group 1
arm group label: Group 2
intervention type: Drug
intervention name: CJ-30056 20/500mg (Test)
description: Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.
Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jong-lyul Ghim, MD. PhD
role: Principal Investigator
affiliation: Inje University
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Metformin
mesh term: Atorvastatin