<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/NCT02194296</url>
  </required_header>
  <id_info>
    <org_study_id>18.479</org_study_id>
    <nct_id>NCT02194296</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of Ambroxol Hydrochloride Lozenge in Comparison to Ambroxol Hydrochloride Syrup (Mucosolvan®) in Healthy Female and Male Volunteers</brief_title>
  <official_title>An Open Label, Randomised, Two-way Crossover Study in Healthy Female and Male Volunteers to Evaluate the Relative Bioavailability of a 20 mg Ambroxol Hydrochloride Lozenge in Comparison to 30 mg Ambroxol Hydrochloride Syrup (Mucosolvan®)</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 relative bioavailability of a 20 mg ambroxol hydrochloride lozenge&#xD;
      compared to 30 mg ambroxol hydrochloride syrup (Mucosolvan®) after dose normalisation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 1999</start_date>
  <primary_completion_date type="Actual">July 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>Cmax (Maximum observed concentration of the analyte in plasma)</measure>
    <time_frame>predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax (Time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-t (Total area under the plasma concentration-time curve from time of administration to the last quantifiable drug concentration)</measure>
    <time_frame>predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (Terminal rate constant in Plasma)</measure>
    <time_frame>predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTtot (Total mean residence time )</measure>
    <time_frame>predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (Apparent clearance of the analyte in plasma following extravascular administration)</measure>
    <time_frame>predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (Apparent volume of distribution of the analyte during the terminal phase)</measure>
    <time_frame>predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 26 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>up to 26 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 26 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Ambroxol hydrochloride - lozenge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ambroxol hydrochloride - syrup</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mucosolvan®</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ambroxol hydrochloride - lozenge</intervention_name>
    <arm_group_label>Ambroxol hydrochloride - lozenge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ambroxol hydrochloride - syrup</intervention_name>
    <arm_group_label>Ambroxol hydrochloride - syrup</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants in the study should be healthy males and females&#xD;
&#xD;
          -  Ages range from 18 to 55 years&#xD;
&#xD;
          -  Broca Index of &gt; -20% and &lt; +20 %&#xD;
&#xD;
          -  Prior to admission of study all volunteers will have given their written informed&#xD;
             consent in accordance with Good Clinical Practice (GCP) and the local legislation&#xD;
&#xD;
          -  Each subject will have his medical history taken and will receive a complete medical&#xD;
             examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead&#xD;
             Electrocardiogram (ECG)&#xD;
&#xD;
          -  Haematopoietic, hepatic and renal function tests will be carried out in the laboratory&#xD;
&#xD;
          -  The subjects will fast for 12 hours before collection of specimens for all laboratory&#xD;
             evaluations. The above mentioned examinations will be performed within 14 days before&#xD;
             the first administration to the test substance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers will be excluded from the study if the results of the medical examination&#xD;
             or laboratory test are judged by the clinical investigator to differ significantly&#xD;
             from normal clinical values&#xD;
&#xD;
          -  Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic immunological or hormonal disorders&#xD;
&#xD;
          -  Volunteers with diseases 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 is&#xD;
             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 one month&#xD;
             before enrolment in the study&#xD;
&#xD;
          -  Volunteers who received any other drugs which might influence the results of the trial&#xD;
             during the week previous to the start of the study&#xD;
&#xD;
          -  Volunteers who have participated in another study with an investigational drug within&#xD;
             the last two months preceding this study&#xD;
&#xD;
          -  Volunteers who smoke (more than 10 cigarettes or 3 cigars or 3 pipes/day)&#xD;
&#xD;
          -  Volunteers who are not able to refrain from smoking on study days&#xD;
&#xD;
          -  Volunteers who drink more than 60 g of alcohol per day&#xD;
&#xD;
          -  Volunteers who are dependent on drugs&#xD;
&#xD;
          -  Volunteers who have participated in excessive physical activities (e.g. competitive&#xD;
             sports) within the last week before the study&#xD;
&#xD;
          -  Volunteers who have donated blood (&gt; 100 ml) within the last 4 weeks prior to&#xD;
             administration&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  No adequate contraception e.g. sterilization, Intrauterine Devices (IUD), oral&#xD;
             contraceptives&#xD;
&#xD;
          -  Inability to maintain this adequate contraception during the whole study period&#xD;
&#xD;
          -  Lactation period&#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>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/18/18.479_U00-1040.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 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>Ambroxol</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/NCT02194296
org study id: 18.479
nct id: NCT02194296
lead sponsor: 
Study to investigate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge
      compared to 30 mg ambroxol hydrochloride syrup (Mucosolvan®) after dose normalisation
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: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
measure: AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
measure: Tmax (Time from dosing to the maximum concentration of the analyte in plasma)
time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
measure: AUC0-t (Total area under the plasma concentration-time curve from time of administration to the last quantifiable drug concentration)
time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
measure: λz (Terminal rate constant in Plasma)
time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
measure: MRTtot (Total mean residence time )
time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
measure: CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
measure: Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
time frame: predose, 0.25, 0.5,.0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours postdose
measure: Number of patients with adverse events
time frame: up to 26 days
measure: Number of patients with clinically significant changes in vital signs
time frame: up to 26 days
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 26 days
arm group label: Ambroxol hydrochloride - lozenge
arm group type: Experimental
arm group label: Ambroxol hydrochloride - syrup
arm group type: Active Comparator
description: Mucosolvan®
intervention type: Drug
intervention name: Ambroxol hydrochloride - lozenge
arm group label: Ambroxol hydrochloride - lozenge
intervention type: Drug
intervention name: Ambroxol hydrochloride - syrup
arm group label: Ambroxol hydrochloride - syrup
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/18/18.479_U00-1040.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Ambroxol