<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/NCT01690975</url>
  </required_header>
  <id_info>
    <org_study_id>B3551001</org_study_id>
    <secondary_id>BT-10-29</secondary_id>
    <nct_id>NCT01690975</nct_id>
  </id_info>
  <brief_title>Benzonatate Dose Tolerance Study</brief_title>
  <official_title>A Phase I, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Tolerability of Benzonatate Following Single Dose Administration in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <brief_summary>
    <textblock>
      This is a single-center, randomized, third party blind, placebo controlled, dose escalation&#xD;
      study of benzonatate following single dose administration. The primary oobjective is to&#xD;
      assess the safety and tolerability of increasing oral doses of benzonatate following single&#xD;
      dose administration in healthy male and female subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t1/2)</measure>
    <time_frame>0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)</measure>
    <time_frame>0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum tolerated dose (MTD): Assessed at end of study</measure>
    <time_frame>End of study (2 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Cough</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benzonatate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Benzonatate Active</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo - single dose at start of each treatment period</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Benzonatate - 400 mg</intervention_name>
    <description>Benzonatate - 400 mg single dose</description>
    <arm_group_label>Benzonatate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Benzonatate - 600 mg</intervention_name>
    <description>Benzonatate - 600 mg single dose</description>
    <arm_group_label>Benzonatate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.&#xD;
             Healthy is defined as no clinically relevant abnormalities identified by a detailed&#xD;
             medical history, full physical examination, including blood pressure and pulse rate&#xD;
             measurement, 12 lead ECG, or clinical laboratory tests.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at the time of dosing).&#xD;
&#xD;
        Any other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
        abnormality that may increase the risk associated with study participation or&#xD;
        investigational product administration or may interfere with the interpretation of study&#xD;
        results, and in the judgment of the investigator, would make the subject inappropriate for&#xD;
        entry into this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pfizer Investigational Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3551001&amp;StudyName=Benzonatate%20Dose%20Tolerance%20Study</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>July 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>September 19, 2012</last_update_submitted>
  <last_update_submitted_qc>September 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2012</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>Benzonatate</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/NCT01690975
org study id: B3551001
secondary id: BT-10-29
nct id: NCT01690975
lead sponsor: 
This is a single-center, randomized, third party blind, placebo controlled, dose escalation
      study of benzonatate following single dose administration. The primary oobjective is to
      assess the safety and tolerability of increasing oral doses of benzonatate following single
      dose administration in healthy male and female subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
measure: Plasma Decay Half-Life (t1/2)
time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose
measure: Maximum tolerated dose (MTD): Assessed at end of study
time frame: End of study (2 months)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Control
arm group label: Benzonatate
arm group type: Experimental
description: Benzonatate Active
intervention type: Drug
intervention name: Placebo
description: Placebo - single dose at start of each treatment period
arm group label: Placebo
intervention type: Drug
intervention name: Benzonatate - 400 mg
description: Benzonatate - 400 mg single dose
arm group label: Benzonatate
intervention type: Drug
intervention name: Benzonatate - 600 mg
description: Benzonatate - 600 mg single dose
arm group label: Benzonatate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3551001&StudyName=Benzonatate%20Dose%20Tolerance%20Study
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Benzonatate