<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/NCT01728740</url>
  </required_header>
  <id_info>
    <org_study_id>15420</org_study_id>
    <nct_id>NCT01728740</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study for Acarbose / Metformin FDC</brief_title>
  <official_title>Randomized, Non-blinded Crossover Study to Establish the Bioequivalence Between Fixed Dose Combination (FDC) and Loose Combination of Acarbose and Metformin and to Investigate the Potential for a Drug-drug Interaction Following Single Oral Dosing in Healthy Adult Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose&#xD;
      combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)</measure>
    <time_frame>within 4 hours after sucrose load</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)</measure>
    <time_frame>within 4 hours after sucrose load</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of metformin</measure>
    <time_frame>within 24 hours after dosing</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-tn) of metformin</measure>
    <time_frame>within 24 hours after dosing</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetes Mellitus, Type II</condition>
  <arm_group>
    <arm_group_label>Acarbose/Metformin FDC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Acarbose/Metformin FDC; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose/Metformin FDC (containing 50 mg Acarbose and 500 mg Metformin)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acarbose+Metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acarbose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose 50 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Metformin 500 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acarbose/Metformin FDC (BAY81-9783)</intervention_name>
    <description>Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose</description>
    <arm_group_label>Acarbose/Metformin FDC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acarbose (Glucobay, BAYG5421)</intervention_name>
    <description>Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose</description>
    <arm_group_label>Acarbose</arm_group_label>
    <arm_group_label>Acarbose+Metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Metformin 500mg, oral, single dose</description>
    <arm_group_label>Acarbose+Metformin</arm_group_label>
    <arm_group_label>Metformin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)&#xD;
&#xD;
          -  Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range&#xD;
             (4.3-5.6%, inclusive)&#xD;
&#xD;
          -  Results of the 75 g oral glucose tolerance test (OGTT) during screening show:&#xD;
&#xD;
               -  Blood glucose before OGTT &lt;110 mg/dL.&#xD;
&#xD;
               -  Blood glucose 1 hour after glucose loading &lt;180 mg/dL&#xD;
&#xD;
               -  Blood glucose 2 hours after glucose loading &lt;140 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of relevant diseases of internal organs (diabetes mellitus, Ileus,&#xD;
             Ileus-like symptoms, diseases that may significantly jeopardize body systems&#xD;
&#xD;
          -  Febrile illness within 1 week before drug administration&#xD;
&#xD;
          -  Family history of diabetes (within the second degree of relationship)&#xD;
&#xD;
          -  Known drug hypersensitivity or idiosyncrasy&#xD;
&#xD;
          -  Known severe allergies, non-allergic drug reactions, or multiple drug allergies&#xD;
&#xD;
          -  Habitual medication including Chinese herbal drugs&#xD;
&#xD;
          -  Intake of any drugs within 2 weeks of drug administration of period 1&#xD;
&#xD;
          -  Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of&#xD;
             approximately 40 g of alcohol in another form&#xD;
&#xD;
          -  Donation of more than 150 mL of blood within 4 weeks before the screening examination&#xD;
&#xD;
          -  Participation in another clinical trial within 4 weeks before the screening&#xD;
             examination&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>December 18, 2012</last_update_submitted>
  <last_update_submitted_qc>December 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2012</last_update_posted>
  <responsible_party>
    <name_title>Head of Clinical Sciences</name_title>
    <organization>Bayer Healthcare AG</organization>
  </responsible_party>
  <keyword>Bioequivalence</keyword>
  <keyword>Acarbose</keyword>
  <keyword>Metformin</keyword>
  <keyword>FDC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Acarbose</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/NCT01728740
org study id: 15420
nct id: NCT01728740
lead sponsor: 
has dmc: No
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose
      combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
time frame: within 4 hours after sucrose load
measure: Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
time frame: within 4 hours after sucrose load
measure: Cmax of metformin
time frame: within 24 hours after dosing
measure: AUC(0-tn) of metformin
time frame: within 24 hours after dosing
arm group label: Acarbose/Metformin FDC
arm group type: Experimental
description: Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Acarbose/Metformin FDC; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose/Metformin FDC (containing 50 mg Acarbose and 500 mg Metformin)
arm group label: Acarbose+Metformin
arm group type: Active Comparator
description: Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg
arm group label: Acarbose
arm group type: Active Comparator
description: Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose 50 mg
arm group label: Metformin
arm group type: Active Comparator
description: Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Metformin 500 mg
intervention type: Drug
intervention name: Acarbose/Metformin FDC (BAY81-9783)
description: Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose
arm group label: Acarbose/Metformin FDC
intervention type: Drug
intervention name: Acarbose (Glucobay, BAYG5421)
description: Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose
arm group label: Acarbose
arm group label: Acarbose+Metformin
intervention type: Drug
intervention name: Metformin
description: Metformin 500mg, oral, single dose
arm group label: Acarbose+Metformin
arm group label: Metformin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Korea, Republic of
name title: Head of Clinical Sciences
organization: Bayer Healthcare AG
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Acarbose