<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/NCT02187575</url>
  </required_header>
  <id_info>
    <org_study_id>107.259</org_study_id>
    <nct_id>NCT02187575</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers</brief_title>
  <official_title>Bioequivalence Study of UHAC62XX 10 mg Tablets Compared With 10 mg Capsules Following Multiple Peroral Administration in Healthy Volunteers (An Open-label, Randomised, Two-way Crossover 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>
      Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules&#xD;
      (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2002</start_date>
  <primary_completion_date type="Actual">September 2002</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>Cmax (maximum observed concentration of the analyte in plasma)</measure>
    <time_frame>up to day 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-τ (Area under the concentration time curve in plasma from zero time to 24 hours after 7-day administration)</measure>
    <time_frame>up to day 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax (Time to reach Cmax)</measure>
    <time_frame>up to day 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 (Terminal half-life in plasma)</measure>
    <time_frame>up to day 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT 0-τ (Mean residence time in the body after 7-day administration)</measure>
    <time_frame>up to day 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cτ (Concentration of the analyte in plasma 24 hours after 7-day administration)</measure>
    <time_frame>up to day 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 20 days after final administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>UHAC 62 XX tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>UHAC 62 XX capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UHAC 62 XX tablet</intervention_name>
    <arm_group_label>UHAC 62 XX tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UHAC 62 XX capsule</intervention_name>
    <arm_group_label>UHAC 62 XX capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 20 and &lt;= 35 years&#xD;
&#xD;
          -  Weight: Body Mass Index &gt;= 18.5 and &lt; 25&#xD;
&#xD;
          -  Subjects who are judged by the investigator to be appropriate as the subjects of the&#xD;
             study based on results of screening test&#xD;
&#xD;
          -  Subjects who volunteer to participate and are able to fully understand and agree with&#xD;
             this study by written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of gastrointestinal ulcer or surgery of gastrointestinal tract (except&#xD;
             appendectomy)&#xD;
&#xD;
          -  History of hypersensitivity to UHAC 62 XX and/or salicylate (aspirin etc.) and/or&#xD;
             Non-steroidal anti-inflammatory drugs (NSAIDs)&#xD;
&#xD;
          -  History of aspirin induced asthma (bronchial asthma induced by NSAIDs)&#xD;
&#xD;
          -  History of bleeding tendency&#xD;
&#xD;
          -  History of alcohol or drug abuse&#xD;
&#xD;
          -  Participation to another trial with an investigational drug within 4 months prior to&#xD;
             the trial&#xD;
&#xD;
          -  Whole blood donation more than 400 ml within 3 months prior to the trial&#xD;
&#xD;
          -  Whole blood donation more than 100 ml within 1 month prior to the trial&#xD;
&#xD;
          -  Donation of constituent of blood of more than 400 ml within 1 month prior to the trial&#xD;
&#xD;
          -  Any medication which might influence the results of the trial within 10 days prior to&#xD;
             the trial&#xD;
&#xD;
          -  Excessive physical activities within 7 days prior to the trial&#xD;
&#xD;
          -  Alcohol drinking within 3 days prior to the trial&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Other than above, those who are judged by the investigator to be inappropriate as the&#xD;
             subjects of the study&#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/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.259_U03-3093.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02187575
org study id: 107.259
nct id: NCT02187575
lead sponsor: 
Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules
      (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (maximum observed concentration of the analyte in plasma)
time frame: up to day 8
measure: AUC 0-τ (Area under the concentration time curve in plasma from zero time to 24 hours after 7-day administration)
time frame: up to day 8
measure: Tmax (Time to reach Cmax)
time frame: up to day 8
measure: T1/2 (Terminal half-life in plasma)
time frame: up to day 8
measure: MRT 0-τ (Mean residence time in the body after 7-day administration)
time frame: up to day 8
measure: Cτ (Concentration of the analyte in plasma 24 hours after 7-day administration)
time frame: up to day 8
measure: Number of patients with adverse events
time frame: up to 20 days after final administration
arm group label: UHAC 62 XX tablet
arm group type: Experimental
arm group label: UHAC 62 XX capsule
arm group type: Active Comparator
intervention type: Drug
intervention name: UHAC 62 XX tablet
arm group label: UHAC 62 XX tablet
intervention type: Drug
intervention name: UHAC 62 XX capsule
arm group label: UHAC 62 XX capsule
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.259_U03-3093.pdf
description: Related Info
responsible party type: Sponsor