<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/NCT03787043</url>
  </required_header>
  <id_info>
    <org_study_id>MP_C102</org_study_id>
    <nct_id>NCT03787043</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Food on Fixed-Dose Combination of MP-513 10 mg and Metformin XR 750 mg</brief_title>
  <official_title>A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Evaluate the Effect of Food on the Safety and Pharmacokinetics of Fixed-dose Combination of MP-513 10mg and Metformin XR 750mg in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Handok Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Handok Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the safety and pharmacokinetic characteristics of&#xD;
      fixed-dose combination of MP-513 10mg and metformin XR 750mg administered in a high fat fed&#xD;
      state versus fasting state to healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Randomized, open-label, single-dosing, two-treatment, two-sequence, two-period,&#xD;
           crossover design&#xD;
&#xD;
        2. Wash-out period: 14 days from the first dosing&#xD;
&#xD;
        3. Drug concentration analytical device: UPLC-MS/MS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC of MP-513 and metformin</measure>
    <time_frame>0(pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose for each period(a total of 36 times, with 18 times per period)</time_frame>
    <description>PK</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of MP-513 and metformin</measure>
    <time_frame>0(pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose for each period(a total of 36 times, with 18 times per period)</time_frame>
    <description>PK</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Sequence Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1st period: FDC(MP-513 10mg/Metformin XR 750mg) under fasted&#xD;
2nd period: FDC(MP-513 10mg/Metformin XR 750mg) under fed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1st period: FDC(MP-513 10mg/Metformin XR 750mg) under fed&#xD;
2nd period: FDC(MP-513 10mg/Metformin XR 750mg) under fasted</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FDC(MP-513 10mg/Metformin XR 750mg)</intervention_name>
    <arm_group_label>Sequence Group A</arm_group_label>
    <arm_group_label>Sequence Group B</arm_group_label>
    <other_name>HL1511</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A healthy male adult at the age of 20 to 45 (both inclusive) at the time of screening&#xD;
             test.&#xD;
&#xD;
          -  Body weight equal to or greater than 55 kg and calculated ideal body weight (IBW)&#xD;
             within ±20%&#xD;
&#xD;
          -  An individual who has been given and fully understood detailed explanations about this&#xD;
             study, decides to participate in the study of his own will, and provides written&#xD;
             informed consent to comply with instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of any clinically significant diseases in the hepatobiliary,&#xD;
             renal, nervous(central or peripheral), respiratory, hemato-oncology, cardiovascular,&#xD;
             urinary, musculoskeletal, immune, ear, nose and throat (ENT), mental, and,&#xD;
             particularly, endocrine systems (e.g., diabetes mellitus, hyperlipidemia, etc.).&#xD;
&#xD;
          -  History of any gastrointestinal disease that may affect absorption of the study drug&#xD;
             (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal&#xD;
             surgeries (except for simple appendectomy or hernia repair).&#xD;
&#xD;
          -  Hypersensitivity to MP-513 or drugs containing metformin or other drugs in the same&#xD;
             class as ingredients or to other drugs&#xD;
&#xD;
          -  Vital signs in a sitting position corresponding to at least one of the following&#xD;
             criteria: systolic blood pressure ≥ 140 mmHg or &lt; 90 mmHg, or diastolic blood pressure&#xD;
             ≥ 95 mmHg or &lt; 60 mmHg.&#xD;
&#xD;
          -  Serum creatine &gt; upper limit of reference range&#xD;
&#xD;
          -  Required to refrain from food intake for at least 24 hours during the study period due&#xD;
             to surgery or religious reason.&#xD;
&#xD;
          -  History or presence of drug abuse.&#xD;
&#xD;
          -  Administration of drugs that either induce or inhibit drug metabolizing enzymes, such&#xD;
             as barbitals, within 1 month prior to the first dosing.&#xD;
&#xD;
          -  Intake of food or beverage containing grapefruit or cranberry within 1 week prior to&#xD;
             the first dosing.&#xD;
&#xD;
          -  Administration of any ethical drugs or traditional Korean herbal medicines within 2&#xD;
             weeks or any over-the-counter drugs or vitamin products within 1 week prior to the&#xD;
             first dosing&#xD;
&#xD;
          -  An individual who participated in another clinical trial and was administered any&#xD;
             investigational product within 3 months prior to the first dosing.&#xD;
&#xD;
          -  Whole blood donation within 2 months, apheresis donation within 1 month, or blood&#xD;
             transfusion within 1 month prior to the first dosing.&#xD;
&#xD;
          -  An individual who drinks excessive amounts of alcohol or who cannot stop drinking&#xD;
             alcohol from 24 hours prior to hospital admission through to hospital discharge.&#xD;
&#xD;
          -  Having smoked 10 cigarettes/day or more on average over the past 3 months.&#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>Clinical trials center of Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <state>Jung-gu</state>
        <zip>301-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 5, 2015</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Food Effect</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03787043
org study id: MP_C102
nct id: NCT03787043
lead sponsor: 
has dmc: No
The purpose of this study is to compare the safety and pharmacokinetic characteristics of
      fixed-dose combination of MP-513 10mg and metformin XR 750mg administered in a high fat fed
      state versus fasting state to healthy male volunteers.
1. Randomized, open-label, single-dosing, two-treatment, two-sequence, two-period,
           crossover design

        2. Wash-out period: 14 days from the first dosing

        3. Drug concentration analytical device: UPLC-MS/MS
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: AUC of MP-513 and metformin
time frame: 0(pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose for each period(a total of 36 times, with 18 times per period)
description: PK
measure: Cmax of MP-513 and metformin
time frame: 0(pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose for each period(a total of 36 times, with 18 times per period)
description: PK
arm group label: Sequence Group A
arm group type: Experimental
description: 1st period: FDC(MP-513 10mg/Metformin XR 750mg) under fasted
2nd period: FDC(MP-513 10mg/Metformin XR 750mg) under fed
arm group label: Sequence Group B
arm group type: Experimental
description: 1st period: FDC(MP-513 10mg/Metformin XR 750mg) under fed
2nd period: FDC(MP-513 10mg/Metformin XR 750mg) under fasted
intervention type: Drug
intervention name: FDC(MP-513 10mg/Metformin XR 750mg)
arm group label: Sequence Group A
arm group label: Sequence Group B
other name: HL1511
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
sharing ipd: Yes