<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/NCT02186483</url>
  </required_header>
  <id_info>
    <org_study_id>JLP_1310-P1-DI</org_study_id>
    <nct_id>NCT02186483</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin</brief_title>
  <official_title>An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Following Coadministration of Metformin and Rosuvastatin 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>
      The purpose of this study is to investigate the pharmacokinetic drug interaction between&#xD;
      Metformin and Rosuvastatin in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy&#xD;
      Male Volunteers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 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>Cmax,ss, AUCτ</measure>
    <time_frame>32h</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax,ss</measure>
    <time_frame>32h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2</measure>
    <time_frame>32h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin,ss</measure>
    <time_frame>32h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/Fss</measure>
    <time_frame>32h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd/Fss</measure>
    <time_frame>32h</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hyperlipidemia</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Co-administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Metformin,1000mg, once daily</description>
    <arm_group_label>Co-administration</arm_group_label>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <other_name>Glucodown OR SR tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>Rosuvastatin, 20 mg, once daily</description>
    <arm_group_label>Co-administration</arm_group_label>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <other_name>Crestor tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin and Rosuvastatin</intervention_name>
    <description>Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily</description>
    <arm_group_label>Co-administration</arm_group_label>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <other_name>Glucodown OR SR tablet and Crestor tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  19~55 years healthy male&#xD;
&#xD;
          -  BMI measurement 19.0kg/m^2~ 28.0kg/m^2&#xD;
&#xD;
          -  Signed informed consent form from to participate voluntarily and to comply with the&#xD;
             trial requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically significant kidney, liver, gastro-intestinal system,&#xD;
             cardiovascular system, respiratory system, tumor or blood disorders, nervous system,&#xD;
             immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood&#xD;
             disorders, obsessive-compulsive disorder, etc.)&#xD;
&#xD;
          -  SBP&gt;140mmHg or &lt;90mmHg, DBP&gt;90mmHg or &lt;60mmHg.&#xD;
&#xD;
          -  An impossible one who participants in clinical trial by investigator's decision&#xD;
             including laboratory test result or another reason.&#xD;
&#xD;
          -  History of drug abuse&#xD;
&#xD;
          -  A alcohol consumer(alcohol&gt;140g/week) or smoker(cigarette&gt;10 cigarettes/day)&#xD;
             Hypersensitivity reaction in history of investigational drugs or specific&#xD;
             drugs(aspirin, antibiotics)&#xD;
&#xD;
          -  Administrated investigational product in a previous clinical trial within 60 days of&#xD;
             the screening day in this study.&#xD;
&#xD;
          -  Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30&#xD;
             days of the screening day in this study.(ex: proton pump inhibitor, rifampicin)&#xD;
&#xD;
          -  Glomerular filtration rate&lt;60mL/min&#xD;
&#xD;
          -  Donated blood within 60 days prior to the screening day or apheresis blood within 30&#xD;
             days prior to the screening day .&#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>Jung-ryul Kim, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center(SMC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center(SMC)</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-Gu</state>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</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/NCT02186483
org study id: JLP_1310-P1-DI
nct id: NCT02186483
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the pharmacokinetic drug interaction between
      Metformin and Rosuvastatin in healthy male volunteers.
Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy
      Male Volunteers
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax,ss, AUCτ
time frame: 32h
measure: Tmax,ss
time frame: 32h
measure: t1/2
time frame: 32h
measure: Cmin,ss
time frame: 32h
measure: CL/Fss
time frame: 32h
measure: Vd/Fss
time frame: 32h
arm group label: Metformin
arm group type: Experimental
description: Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration
arm group label: Rosuvastatin
arm group type: Experimental
description: Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin
arm group label: Co-administration
arm group type: Experimental
description: Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin
intervention type: Drug
intervention name: Metformin
description: Metformin,1000mg, once daily
arm group label: Co-administration
arm group label: Metformin
arm group label: Rosuvastatin
other name: Glucodown OR SR tablet
intervention type: Drug
intervention name: Rosuvastatin
description: Rosuvastatin, 20 mg, once daily
arm group label: Co-administration
arm group label: Metformin
arm group label: Rosuvastatin
other name: Crestor tablet
intervention type: Drug
intervention name: Metformin and Rosuvastatin
description: Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily
arm group label: Co-administration
arm group label: Metformin
arm group label: Rosuvastatin
other name: Glucodown OR SR tablet and Crestor tablet
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jung-ryul Kim, MD, Ph.D
role: Principal Investigator
affiliation: Samsung Medical Center(SMC)
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hyperlipidemias
mesh term: Metformin
mesh term: Rosuvastatin Calcium
sharing ipd: No