<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/NCT02264093</url>
  </required_header>
  <id_info>
    <org_study_id>506.114</org_study_id>
    <nct_id>NCT02264093</nct_id>
  </id_info>
  <brief_title>Effects on the Airway Lumen of Talsaclidine in Combination With Propranolol in Comparison to the Effects of the Monosubstances in Healthy Elderly Male Volunteers</brief_title>
  <official_title>Effects on the Airway Lumen of Single Oral Doses of Talsaclidine (12, 24, 48 and 60 mg) in Combination With a Single Oral Doses of 160 mg Propranolol in Comparison to the Effects of the Monosubstances (60 mg Talsaclidine and 160 mg Propranolol) in Healthy Elderly Male Volunteers (Partially Randomised, Open Label, Intraindividual Comparison)</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 investigate the effects on airway lumen of talsaclidine in combination with propranolol&#xD;
      and of talsaclidine and propranolol given as monosubstances&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 1999</start_date>
  <primary_completion_date type="Actual">February 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>Airway resistance (Raw)</measure>
    <time_frame>Up to 8 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Specific conductance (SGaw)</measure>
    <time_frame>Up to 8 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced expiratory volume in 1 sec (FEV1)</measure>
    <time_frame>Up to 8 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in vital signs</measure>
    <time_frame>Up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant findings in laboratory tests</measure>
    <time_frame>Up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>Up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>Up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC (area under the plasma concentration versus time curve)</measure>
    <time_frame>Up to 12 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Talsaclidine with Propranol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Propranolol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Talsaclidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propranolol</intervention_name>
    <arm_group_label>Propranolol</arm_group_label>
    <arm_group_label>Talsaclidine with Propranol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Talsaclidine</intervention_name>
    <arm_group_label>Talsaclidine</arm_group_label>
    <arm_group_label>Talsaclidine with Propranol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants in the study should be healthy males, range from 50 to 65 years of age and&#xD;
        be within +- 20% of their normal weight (Broca-Index).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers will be excluded from the study if the result of the medical examination or&#xD;
             laboratory tests (especially those which indicate liver malfunction) are judged by the&#xD;
             clinical investigator to differ significantly from the normal clinical values&#xD;
&#xD;
          -  Volunteers with blood pressure lower than 120/80 mm Hg or pulse rate below 60&#xD;
             beats/min&#xD;
&#xD;
          -  Volunteers whose blood pressure dropped below 100/60 mm Hg in the pre-test within 80&#xD;
             mg propranolol&#xD;
&#xD;
          -  Volunteers with Raw-values higher than their predicted normal upper limit&#xD;
&#xD;
          -  Volunteers with known gastrointestinal, hepatic , renal, respiratory, cardiovascular,&#xD;
             metabolic, immunological or hormonal disorders&#xD;
&#xD;
          -  Volunteers with disease of the central nervous system (such as epilepsy) or with&#xD;
             psychiatric disorders&#xD;
&#xD;
          -  Volunteers with known history of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Volunteers with chronic or relevant acute infections&#xD;
&#xD;
          -  Volunteers with history of allergy / hypersensitivity (including drug allergy) which&#xD;
             is deemed relevant to the trial as judged by the investigator&#xD;
&#xD;
          -  Volunteers who have taken a drug with a long half life (&gt;=24 hours) within at least&#xD;
             one month or less than ten half lives of the respective drug before enrolment in the&#xD;
             study&#xD;
&#xD;
          -  Volunteers who received any other drugs which might influence the results of the trial&#xD;
             during the week prior the start of the study&#xD;
&#xD;
          -  Volunteers who have participated in another study with an investigational drug within&#xD;
             the last 2 month preceding this study&#xD;
&#xD;
          -  Volunteers who are unable to refrain from smoking on the study days&#xD;
&#xD;
          -  Volunteers who smoke more than 10 cigarettes (or 3 cigars or pipes) per day&#xD;
&#xD;
          -  Volunteers who drink more than 40 g of alcohol per day&#xD;
&#xD;
          -  Volunteers who are dependent on drugs&#xD;
&#xD;
          -  Volunteers who have donated blood (&gt;=100ml) within the last 4 weeks&#xD;
&#xD;
          -  Volunteers who participated in excessive physical activities (e.g. competitive sports)&#xD;
             within the last week before the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 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 13, 2014</study_first_submitted>
  <study_first_submitted_qc>October 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 13, 2014</last_update_submitted>
  <last_update_submitted_qc>October 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 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>Propranolol</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/NCT02264093
org study id: 506.114
nct id: NCT02264093
lead sponsor: 
To investigate the effects on airway lumen of talsaclidine in combination with propranolol
      and of talsaclidine and propranolol given as monosubstances
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Airway resistance (Raw)
time frame: Up to 8 hours after drug administration
measure: Specific conductance (SGaw)
time frame: Up to 8 hours after drug administration
measure: Forced expiratory volume in 1 sec (FEV1)
time frame: Up to 8 hours after drug administration
measure: Number of participants with clinically significant findings in vital signs
time frame: Up to 8 days after last drug administration
measure: Number of participants with clinically significant findings in laboratory tests
time frame: Up to 8 days after last drug administration
measure: Number of participants with adverse events
time frame: Up to 8 days after last drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: Up to 12 hours after drug administration
measure: tmax (time from dosing to maximum measured concentration of the analyte in plasma)
time frame: Up to 12 hours after drug administration
measure: AUC (area under the plasma concentration versus time curve)
time frame: Up to 12 hours after drug administration
arm group label: Talsaclidine with Propranol
arm group type: Experimental
arm group label: Propranolol
arm group type: Active Comparator
arm group label: Talsaclidine
arm group type: Active Comparator
intervention type: Drug
intervention name: Propranolol
arm group label: Propranolol
arm group label: Talsaclidine with Propranol
intervention type: Drug
intervention name: Talsaclidine
arm group label: Talsaclidine
arm group label: Talsaclidine with Propranol
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Propranolol