<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/NCT02260050</url>
  </required_header>
  <id_info>
    <org_study_id>262.284</org_study_id>
    <nct_id>NCT02260050</nct_id>
  </id_info>
  <brief_title>Bioequivalence of the New Formulation of WAL 801 CL Dry Syrup Compared to the Conventional Formulation of WAL 801 CL Dry Syrup in Healthy Male Volunteers</brief_title>
  <official_title>Bioequivalence of 20 mg of the New Formulation of WAL 801 CL Dry Syrup Compared to 20 mg of the Conventional Formulation of WAL 801 CL Dry Syrup Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, 2x2 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>
      To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the&#xD;
      conventional formulation of WAL 801 CL dry syrup&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2004</start_date>
  <primary_completion_date type="Actual">July 2004</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>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to last measurable concentration (AUC0- tz)</measure>
    <time_frame>up to 34 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of the analytes in plasma (Cmax)</measure>
    <time_frame>up to 34 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>up to 34 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration of the analyte in plasma (tmax)</measure>
    <time_frame>up to 34 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant of the analyte in plasma (λz)</measure>
    <time_frame>up to 34 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 34 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body after po administration (MRTpo)</measure>
    <time_frame>up to 34 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 34 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant findings in physical examination</measure>
    <time_frame>up to 34 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant findings in vital signs</measure>
    <time_frame>Up to 34 hours after last drug administration</time_frame>
    <description>blood pressure, pulse rate, body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 48 hours after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>WAL 801 CL new formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>WAL 801 CL conventional formulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WAL 801 CL dry syrup new formulation</intervention_name>
    <arm_group_label>WAL 801 CL new formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WAL 801 CL dry syrup conventional formulation</intervention_name>
    <arm_group_label>WAL 801 CL conventional formulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males according to the following criteria:&#xD;
&#xD;
               -  Based upon a complete medical history, including the physical examination, vital&#xD;
                  signs (blood pressure (BP), pulse rate (PR), body temperature (BT)), 12-lead ECG,&#xD;
                  clinical laboratory tests (including gastric acidity (GA) test)&#xD;
&#xD;
               -  No finding of clinical relevance&#xD;
&#xD;
               -  No evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Age ≥ 20 and Age ≤ 35 years&#xD;
&#xD;
          -  BMI ≥ 18.5 and BMI ≤ 25 kg/m2 (Body Mass Index)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to Screening Phase and prior to&#xD;
             Treatment Phase (Day -1 in Treatment period 1) in accordance with Japanese Good&#xD;
             Clinical Practice (GCP)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  History of surgery of gastrointestinal tract with the exception of appendectomy&#xD;
&#xD;
          -  History of (and/or current) diseases of the central nervous system (such as epilepsy)&#xD;
             or psychiatric disorders or neurological disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Current chronic or relevant acute infections&#xD;
&#xD;
          -  History of hypersensitivity (including drug allergy) or current allergic disorders&#xD;
             which are deemed relevant to the trial by the investigator or the sub-investigators;&#xD;
             e.g. bronchial asthma, allergic rhinitis, atopic dermatitis and food allergy&#xD;
             (excluding asymptomatic seasonal rhinitis/hay fever)&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than 10 half-lives of the respective drug prior to drug administration and during&#xD;
             Treatment Phase&#xD;
&#xD;
          -  Use of any drugs which might reasonably influence the results of the trial based on&#xD;
             the knowledge at the time of protocol preparation, within 10 days prior to&#xD;
             administration and during Treatment Phase&#xD;
&#xD;
          -  Participation in Phase I trial of new chemical entities within 4 months prior to drug&#xD;
             administration and during the trial, or in another clinical trial within 3 months&#xD;
             prior to drug administration and during Treatment Phase&#xD;
&#xD;
          -  Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking during hospitalization&#xD;
&#xD;
          -  Alcohol abuse (more than 60 g/day) (confirmed by interview)&#xD;
&#xD;
          -  Drug abuse (confirmed by interview)&#xD;
&#xD;
          -  Whole blood donation (400 mL within 3 months or more than 100 mL within 4 weeks prior&#xD;
             to drug administration or during the trial) or component blood donation (within 2&#xD;
             weeks prior to drug administration or during Treatment Phase)&#xD;
&#xD;
          -  Excessive physical activities (within 48 hours prior to each treatment period and&#xD;
             during hospitalisation)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of study centre&#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>October 2014</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 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>Epinastine</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/NCT02260050
org study id: 262.284
nct id: NCT02260050
lead sponsor: 
To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the
      conventional formulation of WAL 801 CL dry syrup
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to last measurable concentration (AUC0- tz)
time frame: up to 34 hours after drug administration
measure: Maximum measured concentration of the analytes in plasma (Cmax)
time frame: up to 34 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
time frame: up to 34 hours after drug administration
measure: Time from dosing to the maximum concentration of the analyte in plasma (tmax)
time frame: up to 34 hours after drug administration
measure: Terminal rate constant of the analyte in plasma (λz)
time frame: up to 34 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to 34 hours after drug administration
measure: Mean residence time of the analyte in the body after po administration (MRTpo)
time frame: up to 34 hours after drug administration
measure: Number of patients with clinically significant findings in laboratory tests
time frame: up to 34 hours after last drug administration
measure: Number of patients with clinically significant findings in physical examination
time frame: up to 34 hours after last drug administration
measure: Number of patients with clinically significant findings in vital signs
time frame: Up to 34 hours after last drug administration
description: blood pressure, pulse rate, body temperature
measure: Number of patients with adverse events
time frame: Up to 48 hours after last drug administration
arm group label: WAL 801 CL new formulation
arm group type: Experimental
arm group label: WAL 801 CL conventional formulation
arm group type: Active Comparator
intervention type: Drug
intervention name: WAL 801 CL dry syrup new formulation
arm group label: WAL 801 CL new formulation
intervention type: Drug
intervention name: WAL 801 CL dry syrup conventional formulation
arm group label: WAL 801 CL conventional formulation
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: Epinastine