<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/NCT02192463</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1485</org_study_id>
    <nct_id>NCT02192463</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of Different Oral Viramune Extended Release Formulations Compared to Viramune® Oral Suspension in Healthy Male Volunteers</brief_title>
  <official_title>Relative Bioavailability of Different Oral Viramune Extended Release Formulations Containing 300 mg or 400 mg Compared to 200 mg or 400 mg as One or Two 200 mg IR Tablets Following Administration in Healthy Male Volunteers - an Openlabel, Non-randomized, Parallel Group Study</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 determine the relative bioavailability of different oral Viramune Extended Release&#xD;
      (ER) formulations compared to Viramune® Immediate Release (IR) tablet&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2006</start_date>
  <primary_completion_date type="Actual">August 2006</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <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>up to 144 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>C24 (measured concentration of the analyte in plasma at 24 hours post-dose)</measure>
    <time_frame>24 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax/C24 ratio</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of the analyte in the body after po administration) CL/F (apparent clearance of the analyte in the plasma after extravascular administration)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ka (absorption rate constant)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 36 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>within 8 days after last trial procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP ER 300 mg (KCR 25%) Medium Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP ER 300 mg (KCR 30%) Slow Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP ER 400 mg (KCR 25%) Medium Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP ER 300 mg (KCR 40%) Slow Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP ER 300 mg (ECR 20%) Fast Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP ER 400 mg (KCR 20%) Medium Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP ER 400 mg (KCR 30%) Slow Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP ER 400 mg (KCR 40%) Slow Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP ER 400 mg (ECR 20%) Fast Release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nevirapine IR 1 tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nevirapine IR 2 tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP ER 300 mg (KCR 20%) Medium Release</intervention_name>
    <arm_group_label>Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP ER 300 mg (KCR 25%) Medium Release</intervention_name>
    <arm_group_label>NVP ER 300 mg (KCR 25%) Medium Release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP ER 300 mg (KCR 30%) Slow Release</intervention_name>
    <arm_group_label>NVP ER 300 mg (KCR 30%) Slow Release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP ER 400 mg (KCR 25%) Medium Release</intervention_name>
    <arm_group_label>NVP ER 400 mg (KCR 25%) Medium Release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP ER 300 mg (KCR 40%) Slow Release</intervention_name>
    <arm_group_label>NVP ER 300 mg (KCR 40%) Slow Release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP ER 300 mg (ECR 20%) Fast Release</intervention_name>
    <arm_group_label>NVP ER 300 mg (ECR 20%) Fast Release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP ER 400 mg (KCR 20%) Medium Release</intervention_name>
    <arm_group_label>NVP ER 400 mg (KCR 20%) Medium Release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP ER 400 mg (KCR 30%) Slow Release</intervention_name>
    <arm_group_label>NVP ER 400 mg (KCR 30%) Slow Release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP ER 400 mg (KCR 40%) Slow Release</intervention_name>
    <arm_group_label>NVP ER 400 mg (KCR 40%) Slow Release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP ER 400 mg (ECR 20%) Fast Release</intervention_name>
    <arm_group_label>NVP ER 400 mg (ECR 20%) Fast Release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine immediate release (IR) 200 mg</intervention_name>
    <arm_group_label>Nevirapine IR 1 tablet</arm_group_label>
    <arm_group_label>Nevirapine IR 2 tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males according to the following criteria based upon a complete medical&#xD;
             history, including the physical examination, vital signs (Blood Pressure (BP), Pulse&#xD;
             Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory&#xD;
&#xD;
          -  Age ≥18 and Age ≤50 years&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including BP, PR and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          -  Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders of clinical relevance&#xD;
&#xD;
          -  Surgery of the gastrointestinal tract (except appendectomy and herniotomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within at least one month or less&#xD;
             than 10 half-lives of the respective drug prior to administration or during the trial&#xD;
&#xD;
          -  Use of drugs which might reasonably influence the results of the trial based on the&#xD;
             knowledge at the time of protocol preparation within 10 days prior to administration&#xD;
             or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (more than 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
          -  Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a&#xD;
             corrected QT interval (QTc) &gt;450 ms)&#xD;
&#xD;
          -  A history of additional risk factors for torsade de pointes (e.g., heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
          -  History of disease which affects the present situation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 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/1100/1100.1485_U07-1713.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 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>Nevirapine</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/NCT02192463
org study id: 1100.1485
nct id: NCT02192463
lead sponsor: 
Study to determine the relative bioavailability of different oral Viramune Extended Release
      (ER) formulations compared to Viramune® Immediate Release (IR) tablet
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 144 hours post-dose
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 144 hours post-dose
measure: C24 (measured concentration of the analyte in plasma at 24 hours post-dose)
time frame: 24 hours post-dose
measure: Cmax/C24 ratio
time frame: up to 144 hours post-dose
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: up to 144 hours post-dose
measure: λz (terminal rate constant in plasma)
time frame: up to 144 hours post-dose
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 144 hours post-dose
measure: MRTpo (mean residence time of the analyte in the body after po administration) CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
time frame: up to 144 hours post-dose
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 144 hours post-dose
measure: ka (absorption rate constant)
time frame: up to 144 hours post-dose
measure: Number of patients with adverse events
time frame: up to 36 days
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: within 8 days after last trial procedure
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 144 hours post-dose
arm group label: Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release
arm group type: Experimental
arm group label: NVP ER 300 mg (KCR 25%) Medium Release
arm group type: Experimental
arm group label: NVP ER 300 mg (KCR 30%) Slow Release
arm group type: Experimental
arm group label: NVP ER 400 mg (KCR 25%) Medium Release
arm group type: Experimental
arm group label: NVP ER 300 mg (KCR 40%) Slow Release
arm group type: Experimental
arm group label: NVP ER 300 mg (ECR 20%) Fast Release
arm group type: Experimental
arm group label: NVP ER 400 mg (KCR 20%) Medium Release
arm group type: Experimental
arm group label: NVP ER 400 mg (KCR 30%) Slow Release
arm group type: Experimental
arm group label: NVP ER 400 mg (KCR 40%) Slow Release
arm group type: Experimental
arm group label: NVP ER 400 mg (ECR 20%) Fast Release
arm group type: Experimental
arm group label: Nevirapine IR 1 tablet
arm group type: Active Comparator
arm group label: Nevirapine IR 2 tablets
arm group type: Active Comparator
intervention type: Drug
intervention name: NVP ER 300 mg (KCR 20%) Medium Release
arm group label: Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release
intervention type: Drug
intervention name: NVP ER 300 mg (KCR 25%) Medium Release
arm group label: NVP ER 300 mg (KCR 25%) Medium Release
intervention type: Drug
intervention name: NVP ER 300 mg (KCR 30%) Slow Release
arm group label: NVP ER 300 mg (KCR 30%) Slow Release
intervention type: Drug
intervention name: NVP ER 400 mg (KCR 25%) Medium Release
arm group label: NVP ER 400 mg (KCR 25%) Medium Release
intervention type: Drug
intervention name: NVP ER 300 mg (KCR 40%) Slow Release
arm group label: NVP ER 300 mg (KCR 40%) Slow Release
intervention type: Drug
intervention name: NVP ER 300 mg (ECR 20%) Fast Release
arm group label: NVP ER 300 mg (ECR 20%) Fast Release
intervention type: Drug
intervention name: NVP ER 400 mg (KCR 20%) Medium Release
arm group label: NVP ER 400 mg (KCR 20%) Medium Release
intervention type: Drug
intervention name: NVP ER 400 mg (KCR 30%) Slow Release
arm group label: NVP ER 400 mg (KCR 30%) Slow Release
intervention type: Drug
intervention name: NVP ER 400 mg (KCR 40%) Slow Release
arm group label: NVP ER 400 mg (KCR 40%) Slow Release
intervention type: Drug
intervention name: NVP ER 400 mg (ECR 20%) Fast Release
arm group label: NVP ER 400 mg (ECR 20%) Fast Release
intervention type: Drug
intervention name: Nevirapine immediate release (IR) 200 mg
arm group label: Nevirapine IR 1 tablet
arm group label: Nevirapine IR 2 tablets
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1485_U07-1713.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Nevirapine