<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/NCT02218658</url>
  </required_header>
  <id_info>
    <org_study_id>263.507</org_study_id>
    <nct_id>NCT02218658</nct_id>
  </id_info>
  <brief_title>Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males</brief_title>
  <official_title>The Bioequivalence Between WE 941 OD Tablets (0.25mg as the Basis) Taken Without Water and Brotizolam Conventional Tablets (Lendormin® Tablets, 0.25 mg as the Basis) Taken With Water, as a Single Administration in Healthy Adult Male Subjects (Open-labelled, 2-way Cross-over Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken&#xD;
      without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was&#xD;
      evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2000</start_date>
  <primary_completion_date type="Actual">August 2000</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>AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum plasma concentration)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time to maximum plasma concentration)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT (Mean residence time)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>WE 941 OD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Brotizolam</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WE941 OD tablets</intervention_name>
    <arm_group_label>WE 941 OD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brotizolam</intervention_name>
    <arm_group_label>Brotizolam</arm_group_label>
    <other_name>Lendormin®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20 and 35 years&#xD;
&#xD;
          -  Weight between 50 and 80 kg&#xD;
&#xD;
          -  Obesity level within the range of +/- 20% of the standard weight according to the Body&#xD;
             Mass Index (BMI) method&#xD;
&#xD;
          -  Judged as eligible as a study object following the screening test by the investigator&#xD;
&#xD;
          -  Volunteers to participate in the study, who are capable of giving written informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to drugs&#xD;
&#xD;
          -  History of drug or alcohol abuse&#xD;
&#xD;
          -  Received other investigational drug within 4 months of the trial drug administration&#xD;
&#xD;
          -  Had &gt; 400 mL of whole blood drawn within 3 months of the trial drug administration&#xD;
&#xD;
          -  Had &gt; 400 mL of blood components drawn within 1 month of the trial drug administration&#xD;
&#xD;
          -  Used any drug within 10 days of the trial drug administration&#xD;
&#xD;
          -  Engaged in strenuous exercise within 5 days of the trial drug administration&#xD;
&#xD;
          -  Consumed alcohol within 3 days of the trial drug administration&#xD;
&#xD;
          -  Judged as ineligible for the study participation by the investigator for a reason&#xD;
             other than above&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</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>Brotizolam</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/NCT02218658
org study id: 263.507
nct id: NCT02218658
lead sponsor: 
The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken
      without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was
      evaluated in healthy adult male subjects (open-labelled, 2-way cross-over study)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)
time frame: up to 24 hours after drug administration
measure: Cmax (maximum plasma concentration)
time frame: up to 24 hours after drug administration
measure: Number of patients with adverse events
time frame: up to 30 days
measure: tmax (time to maximum plasma concentration)
time frame: up to 24 hours after drug administration
measure: MRT (Mean residence time)
time frame: up to 24 hours after drug administration
arm group label: WE 941 OD
arm group type: Experimental
arm group label: Brotizolam
arm group type: Active Comparator
intervention type: Drug
intervention name: WE941 OD tablets
arm group label: WE 941 OD
intervention type: Drug
intervention name: Brotizolam
arm group label: Brotizolam
other name: Lendormin®
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Brotizolam