<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/NCT01662674</url>
  </required_header>
  <id_info>
    <org_study_id>LG-DMCL002</org_study_id>
    <nct_id>NCT01662674</nct_id>
  </id_info>
  <brief_title>BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone</brief_title>
  <official_title>A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LG Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LG Life Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of&#xD;
      the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison&#xD;
      to each component administered in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</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</measure>
    <time_frame>up to 48h post-dose</time_frame>
    <description>To evaluate AUClast of gemigliptin and metformin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>up to 48h post-dose</time_frame>
    <description>To evaluate Cmax of gemigliptin and metformin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUEC</measure>
    <time_frame>up to 48h post-dose</time_frame>
    <description>This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>G+M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of gemigliptin50mg/metformin HCl extended release 1000mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gemigliptin and metformin HCl extended release</intervention_name>
    <description>Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day</description>
    <arm_group_label>G+M</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gemigliptin/metformin HCl extended release</intervention_name>
    <description>Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.</description>
    <arm_group_label>C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20 to 45, healthy male subjects(at screening)&#xD;
&#xD;
          -  Body weight between 55kg - 90kg, BMI between 18.0 - 27.0&#xD;
&#xD;
          -  FPG 70-125mg/dL glucose level(at screening)&#xD;
&#xD;
          -  Subject who totally understand the progress of this clinical trials, make decision by&#xD;
             his free will, and signed a consent form to follow the progress.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who has past or present history of any diseases following below.(liver&#xD;
             including hepatitis virus carrier, kidney,&#xD;
             Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)&#xD;
&#xD;
          -  Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis)&#xD;
             surgery.(appendectomy, hernioplasty are not included)&#xD;
&#xD;
          -  Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)&#xD;
&#xD;
          -  Subject who already participated in other trials in 3months&#xD;
&#xD;
          -  Subject who had whole blood donation in 2months, or component blood donation in&#xD;
             1months or transfusion in 1months currently.&#xD;
&#xD;
          -  Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>April 2, 2015</last_update_submitted>
  <last_update_submitted_qc>April 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 3, 2015</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>
  </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/NCT01662674
org study id: LG-DMCL002
nct id: NCT01662674
lead sponsor: 
has dmc: No
This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of
      the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison
      to each component administered in healthy male volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUClast
time frame: up to 48h post-dose
description: To evaluate AUClast of gemigliptin and metformin
measure: Cmax
time frame: up to 48h post-dose
description: To evaluate Cmax of gemigliptin and metformin
measure: AUEC
time frame: up to 48h post-dose
description: This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.
arm group label: G+M
arm group type: Experimental
description: Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg
arm group label: C
arm group type: Experimental
description: Combination of gemigliptin50mg/metformin HCl extended release 1000mg
intervention type: Drug
intervention name: gemigliptin and metformin HCl extended release
description: Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day
arm group label: G+M
intervention type: Drug
intervention name: gemigliptin/metformin HCl extended release
description: Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.
arm group label: C
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Metformin