<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/NCT02184247</url>
  </required_header>
  <id_info>
    <org_study_id>1071.10</org_study_id>
    <nct_id>NCT02184247</nct_id>
  </id_info>
  <brief_title>Bioavailability of Two Sustained-release Theophylline Products in Healthy Males</brief_title>
  <official_title>A Study to Compare the Bioavailability of Two Sustained-release Theophylline Products</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 compare the bioavailability of 350 mg Bronchoretard® - a sustained-release&#xD;
      theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg&#xD;
      theophylline anhydrous (sustained-release product) by comparing the rate and extent of&#xD;
      absorption of theophylline based on both single and multiple-dose profiles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 1998</start_date>
  <primary_completion_date type="Actual">May 1998</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>Maximum concentration (Cmax)</measure>
    <time_frame>up to 36 hours after first drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time data pairs, with extrapolation to infinity (AUDC)</measure>
    <time_frame>up to 36 hours after first drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time data pairs at steady state (AUDss)</measure>
    <time_frame>up to 12 hours after last administration of study drug</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent peak-to-trough fluctuation (%PTF)</measure>
    <time_frame>up to 12 hours after last administration of study drug</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (Tmax)</measure>
    <time_frame>up to 36 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent terminal half-life (t1/2.z)</measure>
    <time_frame>up to 36 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time data pairs [AUD(0-tlast)], also indicated by AUD, where tlast is the time of the last quantifiable concentration</measure>
    <time_frame>up to 36 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of Cmax and AUDC (Cmax/AUDC)</measure>
    <time_frame>up to 36 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total mean time in the system (MTvsys)</measure>
    <time_frame>up to 36 hours after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration at steady state (Cmax,ss)</measure>
    <time_frame>up to 12 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum concentration at steady state (Cmin,ss)</measure>
    <time_frame>up to 12 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plateau time (T75%Cmax)</measure>
    <time_frame>up to 12 hours after last administration of study drug</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>anhydrous theophylline, 350 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>anhydrous theophylline, 300 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>anhydrous theophylline, 350 mg</intervention_name>
    <arm_group_label>anhydrous theophylline, 350 mg</arm_group_label>
    <other_name>Bronchoretard®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>anhydrous theophylline, 300 mg</intervention_name>
    <arm_group_label>anhydrous theophylline, 300 mg</arm_group_label>
    <other_name>Theo-Dur®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, non-smoking male subjects between 18 and 45 years of age&#xD;
&#xD;
          -  Body weight within 10% of the ideal weight according to the Body Mass Index (BMI)&#xD;
&#xD;
          -  Normal health based on medical history and findings within the range of clinical&#xD;
             acceptability, in respect of the physical examination (including electrocardiogram and&#xD;
             vital signs) and special investigations&#xD;
&#xD;
          -  Ability to comprehend and willingness to sign both statements of informed consent (for&#xD;
             screening and study-specific procedures)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of serious systemic or organ disease&#xD;
&#xD;
          -  A major illness during the 3 months before commencement of the study-related&#xD;
             procedures&#xD;
&#xD;
          -  Significant physical or organ abnormality&#xD;
&#xD;
          -  History of hypersensitivity to theophylline or other xanthine derivatives&#xD;
&#xD;
          -  Use of any medication within 2 weeks before the first administration of study&#xD;
             medication&#xD;
&#xD;
          -  Participation in another study with an experimental drug within 8 weeks before the&#xD;
             first administration of study medication&#xD;
&#xD;
          -  Treatment within the previous 3 months with any drug with a well-defined potential for&#xD;
             adversely affecting a major organ or system (for example chloramphenicol, which may&#xD;
             cause bone marrow suppression)&#xD;
&#xD;
          -  Donation of blood during the 8 weeks before the first administration of study&#xD;
             medication&#xD;
&#xD;
          -  History of, or current compulsive alcohol abuse (&gt; 10 drinks per week), of regular&#xD;
             exposure to other substance of abuse&#xD;
&#xD;
          -  Positive testing for HIV and hepatitis B antigens within the previous 3 months&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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/1071/1071.10_U02-3426.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 8, 2014</last_update_submitted>
  <last_update_submitted_qc>July 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 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>Theophylline</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/NCT02184247
org study id: 1071.10
nct id: NCT02184247
lead sponsor: 
Study to compare the bioavailability of 350 mg Bronchoretard® - a sustained-release
      theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg
      theophylline anhydrous (sustained-release product) by comparing the rate and extent of
      absorption of theophylline based on both single and multiple-dose profiles.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum concentration (Cmax)
time frame: up to 36 hours after first drug administration
measure: Area under the plasma concentration versus time data pairs, with extrapolation to infinity (AUDC)
time frame: up to 36 hours after first drug administration
measure: Area under the plasma concentration versus time data pairs at steady state (AUDss)
time frame: up to 12 hours after last administration of study drug
measure: Percent peak-to-trough fluctuation (%PTF)
time frame: up to 12 hours after last administration of study drug
measure: Time to maximum concentration (Tmax)
time frame: up to 36 hours after first drug administration
measure: Apparent terminal half-life (t1/2.z)
time frame: up to 36 hours after first drug administration
measure: Area under the plasma concentration versus time data pairs [AUD(0-tlast)], also indicated by AUD, where tlast is the time of the last quantifiable concentration
time frame: up to 36 hours after first drug administration
measure: Ratio of Cmax and AUDC (Cmax/AUDC)
time frame: up to 36 hours after first drug administration
measure: Total mean time in the system (MTvsys)
time frame: up to 36 hours after first drug administration
measure: Maximum concentration at steady state (Cmax,ss)
time frame: up to 12 hours after last administration of study drug
measure: Minimum concentration at steady state (Cmin,ss)
time frame: up to 12 hours after last administration of study drug
measure: Plateau time (T75%Cmax)
time frame: up to 12 hours after last administration of study drug
arm group label: anhydrous theophylline, 350 mg
arm group type: Experimental
arm group label: anhydrous theophylline, 300 mg
arm group type: Active Comparator
intervention type: Drug
intervention name: anhydrous theophylline, 350 mg
arm group label: anhydrous theophylline, 350 mg
other name: Bronchoretard®
intervention type: Drug
intervention name: anhydrous theophylline, 300 mg
arm group label: anhydrous theophylline, 300 mg
other name: Theo-Dur®
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1071/1071.10_U02-3426.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Theophylline