<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/NCT02184312</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1517</org_study_id>
    <nct_id>NCT02184312</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Properties of Two Dosages Nevirapine Extended Release (XR) Formulations Compared to VIRAMUNE® Tablet as Well as to Nevirapine XR Tablet in Healthy Male Volunteers</brief_title>
  <official_title>An Open-label, Non-randomised, Single-dose, Parallel-group Study of Pharmacokinetic Properties of 200 mg (2 x 100 mg Tablets Once Daily) and 300 mg (3 x 100 mg Tablets Once Daily) Nevirapine Extended Release Formulations Compared to 200 mg VIRAMUNE® Tablet as Well as to 400 mg Nevirapine Extended Release Tablet Following Oral Administration in Healthy Male Volunteers</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 pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily)&#xD;
      and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to&#xD;
      estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE®&#xD;
      tablet as well as to 400 mg Nevirapine extended release tablet&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2008</start_date>
  <primary_completion_date type="Actual">July 2008</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 after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </primary_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 after drug administration</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 after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of the analyte in the body after po administration)</measure>
    <time_frame>up to 144 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analyte in the plasma after extravascular administration)</measure>
    <time_frame>up to 144 hours after drug administration</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 after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ka (absorption rate constant)</measure>
    <time_frame>up to 144 hours after drug administration</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>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>Screening, Day 1, 2, 3, 4, 5, 7, 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR))</measure>
    <time_frame>Screening, Day 1, 2, 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>Screening, Day 1, 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>up to 15 days after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Nevirapine XR low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nevirapine XR medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nevirapine XR high dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nevirapine (VIRAMUNE®)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>commercial product</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine XR low dose</intervention_name>
    <arm_group_label>Nevirapine XR low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine XR medium dose</intervention_name>
    <arm_group_label>Nevirapine XR medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine XR high dose</intervention_name>
    <arm_group_label>Nevirapine XR high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine (VIRAMUNE®)</intervention_name>
    <arm_group_label>Nevirapine (VIRAMUNE®)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy males according to the following criteria:&#xD;
&#xD;
          -  Based upon a complete medical history, including the physical examination, vital signs&#xD;
             (BP, PR), 12-lead ECG, clinical laboratory; values within normal ranges or deviating&#xD;
             from normal without clinical relevance as considered by the investigator&#xD;
&#xD;
          -  Values of Liver Function Test (LFT) have to be within normal ranges&#xD;
&#xD;
          -  Age ≥18 and Age ≤60 years&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2&#xD;
&#xD;
          -  Subjects must agree to minimize the risk of female partners becoming pregnant from the&#xD;
             first dosing day until 3 months after the completion of the post study medical&#xD;
             examination. Acceptable methods of contraception comprises barrier contraception and a&#xD;
             medically accepted contraceptive method for the female partner (intra-uterine device&#xD;
             with spermicide, hormonal contraceptive since at least two month)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good clinical practice (GCP) 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;
          -  Participation to trial BI 1100.1485 or any other intake of Nevirapine&#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;
             QTc interval &gt;450 ms)&#xD;
&#xD;
          -  A history of additional risk factors for Torsades des Pointes (e.g., heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
          -  History of disease which affects the present situation&#xD;
&#xD;
          -  Inability to understand the protocol requirements, instructions and study-related&#xD;
             restrictions, the nature, scope, and possible consequences of the study&#xD;
&#xD;
          -  Unlikely to comply with the protocol requirements, instructions and study-related&#xD;
             restrictions; e.g., uncooperative attitude, inability to return for follow-up visits,&#xD;
             and improbability of completing the study&#xD;
&#xD;
          -  Subject is the investigator or any sub-investigator, research assistant, pharmacist,&#xD;
             study coordinator, other staff or relative thereof directly involved in the conduct of&#xD;
             the study&#xD;
&#xD;
          -  Vulnerable subjects (e.g. persons kept in detention)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 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/1100/1100.1517_U09-1463-01.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 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 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/NCT02184312
org study id: 1100.1517
nct id: NCT02184312
lead sponsor: 
Study to determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily)
      and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to
      estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE®
      tablet as well as to 400 mg Nevirapine extended release 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 after drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 144 hours after drug administration
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 after drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 144 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 144 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 144 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after po administration)
time frame: up to 144 hours after drug administration
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
time frame: up to 144 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: up to 144 hours after drug administration
measure: ka (absorption rate constant)
time frame: up to 144 hours after drug administration
measure: Number of patients with adverse events
time frame: up to 36 days
measure: Number of patients with abnormal changes in laboratory parameters
time frame: Screening, Day 1, 2, 3, 4, 5, 7, 15
measure: Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR))
time frame: Screening, Day 1, 2, 15
measure: Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
time frame: Screening, Day 1, 15
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: up to 15 days after drug administration
arm group label: Nevirapine XR low dose
arm group type: Experimental
arm group label: Nevirapine XR medium dose
arm group type: Experimental
arm group label: Nevirapine XR high dose
arm group type: Active Comparator
arm group label: Nevirapine (VIRAMUNE®)
arm group type: Active Comparator
description: commercial product
intervention type: Drug
intervention name: Nevirapine XR low dose
arm group label: Nevirapine XR low dose
intervention type: Drug
intervention name: Nevirapine XR medium dose
arm group label: Nevirapine XR medium dose
intervention type: Drug
intervention name: Nevirapine XR high dose
arm group label: Nevirapine XR high dose
intervention type: Drug
intervention name: Nevirapine (VIRAMUNE®)
arm group label: Nevirapine (VIRAMUNE®)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1517_U09-1463-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Nevirapine