<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/NCT02260063</url>
  </required_header>
  <id_info>
    <org_study_id>262.252</org_study_id>
    <nct_id>NCT02260063</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers</brief_title>
  <official_title>A Trial in Healthy Volunteers of the Relative Bioavailability of Epinastine Syrup, a New Galenic Form, Compared to the Reference Product Tablets</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 assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup&#xD;
      and 20 mg tablets&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 1998</start_date>
  <primary_completion_date type="Actual">January 1999</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 curve (AUC) of plasma concentration (CP)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absorption rate Cpmax/AUC</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak plasma concentration (Cpmax)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to peak (Tmax)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug half - life (T1/2)</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to 24 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants withdrawn or discontinued due to safety reasons</measure>
    <time_frame>Up to 24 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal findings in physical examination</measure>
    <time_frame>Up to 24 hours after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in vital signs</measure>
    <time_frame>Up to 24 hours after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Epinastine syrup</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Epinastine tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epinastine syrup</intervention_name>
    <arm_group_label>Epinastine syrup</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epinastine tablets</intervention_name>
    <arm_group_label>Epinastine tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male and female, non-smoker and non-alcohol user, healthy volunteers, of 21 - 45 years&#xD;
             of age. To be eligible, women must not be pregnant or lactating and they must not be&#xD;
             taking hormone contraceptives&#xD;
&#xD;
          -  Volunteers must not have a history of liver or renal disease or a history of&#xD;
             psychiatric disorder. Volunteers will be submitted to the biochemical tests listed&#xD;
             below, the results of which must be within expected normal values: complete blood&#xD;
             count, erythro-sedimentation rate, GOT (glutamate oxalacetate transaminase) GPT&#xD;
             (glutamate pyruvate transaminase), blood creatinine, glycemia, uremia, blood&#xD;
             cholesterol, pregnancy test. HIV test (with prior written consent), serum tests for&#xD;
             Chagas disease, hepatic b and syphilis, complete urinalysis, ECG (electrocardiogram)&#xD;
             and chest x-ray&#xD;
&#xD;
          -  Volunteers must have discontinued all pharmacological treatment at least two weeks&#xD;
             before entering this trial&#xD;
&#xD;
          -  informed written consent, signed prior to the start of this trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers requiring any kind of pharmacological treatment or having some known&#xD;
             addiction&#xD;
&#xD;
          -  Volunteers having participated in any other clinical trial during the four preceding&#xD;
             weeks&#xD;
&#xD;
          -  Volunteers who must start a treatment incompatible with this trial during its course&#xD;
&#xD;
          -  Volunteers who do not comply with the fasting requirements established in the trial or&#xD;
             who do not comply with trial requirements such as avoiding intake of coffee, tea, cola&#xD;
             soft drinks, etc. for 24 hours prior to the start of the trial&#xD;
&#xD;
          -  History of allergy or intolerance to Epinastine&#xD;
&#xD;
          -  Uncooperative volunteers&#xD;
&#xD;
          -  Previous participation in this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 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 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 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/NCT02260063
org study id: 262.252
nct id: NCT02260063
lead sponsor: 
To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup
      and 20 mg tablets
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the curve (AUC) of plasma concentration (CP)
time frame: Up to 24 hours after drug administration
measure: Absorption rate Cpmax/AUC
time frame: Up to 24 hours after drug administration
measure: Peak plasma concentration (Cpmax)
time frame: Up to 24 hours after drug administration
measure: Time to peak (Tmax)
time frame: Up to 24 hours after drug administration
measure: Drug half - life (T1/2)
time frame: Up to 24 hours after drug administration
measure: Number of participants with adverse events
time frame: Up to 24 hours after last drug administration
measure: Number of participants withdrawn or discontinued due to safety reasons
time frame: Up to 24 hours after last drug administration
measure: Number of participants with abnormal findings in physical examination
time frame: Up to 24 hours after last drug administration
measure: Number of participants with clinically significant findings in vital signs
time frame: Up to 24 hours after last drug administration
arm group label: Epinastine syrup
arm group type: Experimental
arm group label: Epinastine tablets
arm group type: Active Comparator
intervention type: Drug
intervention name: Epinastine syrup
arm group label: Epinastine syrup
intervention type: Drug
intervention name: Epinastine tablets
arm group label: Epinastine tablets
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Epinastine