<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/NCT03809260</url>
  </required_header>
  <id_info>
    <org_study_id>MMP</org_study_id>
    <nct_id>NCT03809260</nct_id>
  </id_info>
  <brief_title>A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin</brief_title>
  <official_title>A Clinical Trial for Analysis of Intestinal Microbiome Affecting Pharmacokinetics, Pharmacodynamics, and Safety of Metformin in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is intended to evaluate the effects of the changes in intestinal&#xD;
      microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety&#xD;
      profiles of metformin in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the gut microbiome species change</measure>
    <time_frame>Day 1/4/16/19</time_frame>
    <description>Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare the maximum plasma concentration (Cmax) of metformin</measure>
    <time_frame>Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)</time_frame>
    <description>Compare the maximum plasma concentration (Cmax) of metformin before and after vancomycin PO treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the area under the plasma concentration versus time curve (AUC) of metformin</measure>
    <time_frame>Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)</time_frame>
    <description>Compare the area under the plasma concentration versus time curve (AUC) of metformin before and after vancomycin PO treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the maximum blood glucose concentration (Gmax)</measure>
    <time_frame>Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)</time_frame>
    <description>Oral glucose tolerance test (OGTT); Compare the maximum blood glucose concentration (Gmax) before and after metformin (or vancomycin) PO treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the area under the blood glucose concentration versus time curve (AUC)</measure>
    <time_frame>Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)</time_frame>
    <description>Oral glucose tolerance test (OGTT); Compare the area under the blood glucose concentration versus time curve (AUC) before and after metformin (or vancomycin) PO treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Human Microbiome</condition>
  <arm_group>
    <arm_group_label>Part 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metformin/Vancomycin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metformin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin (part 1)</intervention_name>
    <description>1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d~19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch).</description>
    <arm_group_label>Part 1</arm_group_label>
    <other_name>Diabex Tab., 500 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <description>11d: Vancomycin 250 mg bid, 12~17d: Vancomycin 500 mg bid</description>
    <arm_group_label>Part 1</arm_group_label>
    <other_name>Vancozin cap., 250 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin (part 2)</intervention_name>
    <description>1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)</description>
    <arm_group_label>Part 2</arm_group_label>
    <other_name>Diabex Tab., 500 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 19 to 45, healthy male subjects(at screening)&#xD;
&#xD;
          -  Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2&#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 a past or present history of any diseases following below.(liver,&#xD;
             kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology,&#xD;
             mental disorder)&#xD;
&#xD;
          -  Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic&#xD;
             pancreatitis) or surgery (appendectomy, hernioplasty are excluded)&#xD;
&#xD;
          -  Serum AST(SGOT), ALT(SGPT)&gt;1.5 times upper limit of normal range&#xD;
&#xD;
          -  MDRD eGFR &lt;80mL/min/1.73m2&#xD;
&#xD;
          -  Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction&#xD;
&#xD;
          -  Subject who already participated in other trials in 3 months&#xD;
&#xD;
          -  Subject who had whole blood donation in 2 months, or component blood donation in 1&#xD;
             month or transfusion in 1 month currently.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jae-Yong Chung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SNUBH Clinical trial centor</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Jae Yong Chung, MD, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Vancomycin</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/NCT03809260
org study id: MMP
nct id: NCT03809260
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This clinical trial is intended to evaluate the effects of the changes in intestinal
      microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety
      profiles of metformin in healthy male volunteers.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Compare the gut microbiome species change
time frame: Day 1/4/16/19
description: Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing
measure: Compare the maximum plasma concentration (Cmax) of metformin
time frame: Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)
description: Compare the maximum plasma concentration (Cmax) of metformin before and after vancomycin PO treatment
measure: Compare the area under the plasma concentration versus time curve (AUC) of metformin
time frame: Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)
description: Compare the area under the plasma concentration versus time curve (AUC) of metformin before and after vancomycin PO treatment
measure: Compare the maximum blood glucose concentration (Gmax)
time frame: Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
description: Oral glucose tolerance test (OGTT); Compare the maximum blood glucose concentration (Gmax) before and after metformin (or vancomycin) PO treatment
measure: Compare the area under the blood glucose concentration versus time curve (AUC)
time frame: Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
description: Oral glucose tolerance test (OGTT); Compare the area under the blood glucose concentration versus time curve (AUC) before and after metformin (or vancomycin) PO treatment
arm group label: Part 1
arm group type: Experimental
description: Metformin/Vancomycin
arm group label: Part 2
arm group type: Experimental
description: Metformin
intervention type: Drug
intervention name: Metformin (part 1)
description: 1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d~19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch).
arm group label: Part 1
other name: Diabex Tab., 500 mg
intervention type: Drug
intervention name: Vancomycin
description: 11d: Vancomycin 250 mg bid, 12~17d: Vancomycin 500 mg bid
arm group label: Part 1
other name: Vancozin cap., 250 mg
intervention type: Drug
intervention name: Metformin (part 2)
description: 1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)
arm group label: Part 2
other name: Diabex Tab., 500 mg
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jae-Yong Chung
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Jae Yong Chung, MD, PhD
investigator title: Professor
mesh term: Metformin
mesh term: Vancomycin
sharing ipd: No