<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/NCT02982798</url>
  </required_header>
  <id_info>
    <org_study_id>JLP-1310-103-PK</org_study_id>
    <nct_id>NCT02982798</nct_id>
  </id_info>
  <brief_title>The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers</brief_title>
  <official_title>A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male 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>
      A randomized, open-label, single dose, crossover study to compare the pharmacokinetic&#xD;
      characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in&#xD;
      healthy male volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, open-label, single dose, crossover clinical trial&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2017</start_date>
  <completion_date type="Actual">January 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 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>AUClast of Metformin and rosuvastatin</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Metformin and rosuvastatin</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetes</condition>
  <condition>Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period I: administration of Metformin + Rosuvastatin Period II: JLP-1310</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period I: JLP-1301 Period II: administration of Metformin + Rosuvastatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin + Rosuvastatin</intervention_name>
    <description>administration of Metformin + Rosuvastatin</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JLP-1310</intervention_name>
    <description>administration of JLP-1310</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</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>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>March 28, 2018</last_update_submitted>
  <last_update_submitted_qc>March 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2018</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>Metformin</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/NCT02982798
org study id: JLP-1310-103-PK
nct id: NCT02982798
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized, open-label, single dose, crossover study to compare the pharmacokinetic
      characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in
      healthy male volunteers
A randomized, open-label, single dose, crossover clinical trial
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUClast of Metformin and rosuvastatin
time frame: 48 hours
measure: Cmax of Metformin and rosuvastatin
time frame: 48 hours
arm group label: Group I
arm group type: Experimental
description: Period I: administration of Metformin + Rosuvastatin Period II: JLP-1310
arm group label: Group II
arm group type: Experimental
description: Period I: JLP-1301 Period II: administration of Metformin + Rosuvastatin
intervention type: Drug
intervention name: Metformin + Rosuvastatin
description: administration of Metformin + Rosuvastatin
arm group label: Group I
arm group label: Group II
intervention type: Drug
intervention name: JLP-1310
description: administration of JLP-1310
arm group label: Group I
arm group label: Group II
criteria: 
gender: Male
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hyperlipidemias
mesh term: Metformin
mesh term: Rosuvastatin Calcium
sharing ipd: No