<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/NCT02212782</url>
  </required_header>
  <id_info>
    <org_study_id>DW1029M-I-6</org_study_id>
    <nct_id>NCT02212782</nct_id>
  </id_info>
  <brief_title>the Pharmacokinetic Profiles of Linagliptin With DW1029M</brief_title>
  <acronym>PLID</acronym>
  <official_title>A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Study to Evaluate DW1029M Influence the Pharmacokinetic Profiles of Linagliptin After Oral Administration in Healthy Male Volunteer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong Wha Pharmaceutical Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong Wha Pharmaceutical Co. Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of&#xD;
      Linagliptin after oral administration in healthy male volunteer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M&#xD;
      influence the pharmacokinetic profiles of Linagliptin after oral administration in healthy&#xD;
      male volunteer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">November 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax and AUC</measure>
    <time_frame>1st day and 43rd day, 5th day and 47th day, 6th day and 48th day : Predose(0, morning), 7th day and 49th day : Predose(0), 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour</time_frame>
    <description>Maximum of Concentration(Cmax), Area Under Plasma Concentration-Time Curve(AUC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Profile of Plasma</measure>
    <time_frame>1st day and 43rd day, 5th day and 47th day, 6th day and 48th day : Predose(0, morning), 7th day and 49th day : Predose(0), 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour</time_frame>
    <description>Maximum drug concentration time(Tmax), Half-time(t1/2), Apparent renal clearance(CL/F), Apparent volume of distribution(Vd/F), Fluctuation[(Css,max-Css,min)/Css,av], Swing[(Css,max-Css,min)/Css,min]</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>A Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1st oral administration of Linagliptin 5mg and 2nd oral administration of DW1029M 1200mg and Linagliptin 5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1st oral administration of DW1029M 1200mg and Linagliptin 5mg and 2nd oral administration of Linagliptin 5mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linagliptin 5mg</intervention_name>
    <description>Linagliptin 5mg once daily for 7 days</description>
    <arm_group_label>A Group</arm_group_label>
    <arm_group_label>B Group</arm_group_label>
    <other_name>Trajenta Tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DW1029M 1200mg and Linagliptin 5mg</intervention_name>
    <description>Linagliptin 5mg 1 tablet once daily and DW1029M 300mg 2 tablets b.i.d for 7 days</description>
    <arm_group_label>A Group</arm_group_label>
    <arm_group_label>B Group</arm_group_label>
    <other_name>Concomitant of DW1029M 1200mg and Linagliptin 5mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A healthy adult within the range of 19 to 55 years old at the time of screening&#xD;
&#xD;
          -  Body Mass Index(BMI)=17.5~30.5kg/m2, one with weight of more than 55kg (BMI= kg/(m)2)&#xD;
&#xD;
          -  Congenital or chronic diseases within the last three years, there is no medical&#xD;
             examination results of popular characters with no psychotic symptoms or findings&#xD;
&#xD;
          -  Doctor checks conducted hematology, blood chemistry, urinalysis and laboratory tests,&#xD;
             including an electrocardiogram(EKG) performed during screening tests such as a&#xD;
             suitable test subjects who judged&#xD;
&#xD;
          -  The purpose of the test participants prior to testing, information, and to hear about&#xD;
             the free will fully explain to participate in this study, according to the&#xD;
             Institutional Review Board(IRB)-approved consent form signed by the parties in writing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  one with clinically significant blood, kidneys, endocrine, respiratory,&#xD;
             gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or&#xD;
             allergic disease (but ,except for untreated seasonal allergies of asymptomatic at the&#xD;
             time of administration) with medical history or evidence&#xD;
&#xD;
          -  one with gastrointestinal disease(Such as esophageal stricture or achalasia of the&#xD;
             esophagus disease, Crohn disease) to affect drug absorption or surgery(but, excluding&#xD;
             simple appendectomy or hernia surgery) with medical history&#xD;
&#xD;
          -  Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) &gt; 2 times the upper&#xD;
             limit of the normal range&#xD;
&#xD;
          -  Within 6 months, 210 g / week of alcohol in excess of a history of regular characters&#xD;
             (beer (5%) 1 cup (250 mL) = 10 g, soju(20%) 1 cup (50 mL) = 8 g, Wine (12%) 1 cup (125&#xD;
             mL) = 12 g)&#xD;
&#xD;
          -  Take part in other clinical trials within two months&#xD;
&#xD;
          -  Systolic Blood Pressure(SBP) ≥ 140 mmHg or Diastolic Blood Pressure (DBP) ≥ 90 mmHg&#xD;
&#xD;
          -  The great history of alcohol or drug abuse within 1 year&#xD;
&#xD;
          -  Taking medication of drug-metabolizing enzymes that are known to significantly induce&#xD;
             or inhibit within 30 days&#xD;
&#xD;
          -  More than 20 cigarettes a day smoker&#xD;
&#xD;
          -  Taking medication of a prescription drug or nonprescription within 10 days,&#xD;
&#xD;
          -  Within two months the whole blood donation have, within one month of the apheresis&#xD;
             donation have&#xD;
&#xD;
          -  Participate in clinical trials to test drug administration and may be at increased&#xD;
             risk due to interpretation of test results, or may interfere with severe supply /&#xD;
             chronic medical or mental condition or abnormal laboratory test values in character&#xD;
&#xD;
          -  Patient with hypersensitivity to investigational products or ingredients&#xD;
&#xD;
          -  Patient with Type 1 Diabetes or Diabetic ketoacidosis&#xD;
&#xD;
          -  Described lifestyle in this protocol can comply with or can not&#xD;
&#xD;
          -  One with other investigator judge to unsuitable&#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>Mingul Kim, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <state>Jeollabukdo</state>
        <zip>561-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>June 25, 2015</last_update_submitted>
  <last_update_submitted_qc>June 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Linagliptin</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/NCT02212782
org study id: DW1029M-I-6
nct id: NCT02212782
lead sponsor: 
has dmc: Yes
Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of
      Linagliptin after oral administration in healthy male volunteer.
A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M
      influence the pharmacokinetic profiles of Linagliptin after oral administration in healthy
      male volunteer.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Cmax and AUC
time frame: 1st day and 43rd day, 5th day and 47th day, 6th day and 48th day : Predose(0, morning), 7th day and 49th day : Predose(0), 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour
description: Maximum of Concentration(Cmax), Area Under Plasma Concentration-Time Curve(AUC)
measure: Pharmacokinetic Profile of Plasma
time frame: 1st day and 43rd day, 5th day and 47th day, 6th day and 48th day : Predose(0, morning), 7th day and 49th day : Predose(0), 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour
description: Maximum drug concentration time(Tmax), Half-time(t1/2), Apparent renal clearance(CL/F), Apparent volume of distribution(Vd/F), Fluctuation[(Css,max-Css,min)/Css,av], Swing[(Css,max-Css,min)/Css,min]
arm group label: A Group
arm group type: Experimental
description: 1st oral administration of Linagliptin 5mg and 2nd oral administration of DW1029M 1200mg and Linagliptin 5mg
arm group label: B Group
arm group type: Experimental
description: 1st oral administration of DW1029M 1200mg and Linagliptin 5mg and 2nd oral administration of Linagliptin 5mg
intervention type: Drug
intervention name: Linagliptin 5mg
description: Linagliptin 5mg once daily for 7 days
arm group label: A Group
arm group label: B Group
other name: Trajenta Tablet
intervention type: Drug
intervention name: DW1029M 1200mg and Linagliptin 5mg
description: Linagliptin 5mg 1 tablet once daily and DW1029M 300mg 2 tablets b.i.d for 7 days
arm group label: A Group
arm group label: B Group
other name: Concomitant of DW1029M 1200mg and Linagliptin 5mg
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mingul Kim, M.D
role: Principal Investigator
affiliation: Chonbuk National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Linagliptin