<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/NCT02194218</url>
  </required_header>
  <id_info>
    <org_study_id>1100.1531</org_study_id>
    <nct_id>NCT02194218</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Properties of Nevirapine Extended Release Tablets When Administered Orally in Healthy Male Volunteers</brief_title>
  <official_title>An Open-label, Randomised, Single Dose, Parallel-group Phase I Study to Investigate the Pharmacokinetic Properties of 200 mg Nevirapine Extended Release Tablets When Administered Orally as 2x100 mg Tablets or as 4x50 mg Tablets 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 nevirapine (NVP) administered as&#xD;
      4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence&#xD;
      of this formulation compared to 200 mg NVP administered as 2 x 100 mg XR tablets in a single&#xD;
      dose&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <primary_completion_date type="Actual">November 2009</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of the analyte in plasma (Cmax)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>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 (AUC0-tz)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration of the analyte in plasma (tmax)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant in plasma (λz)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of the analyte in plasma (t1/2)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body after po administration (MRTpo)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)</measure>
    <time_frame>up to 144 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absorption rate constant (ka)</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 35 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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Nevirapine XR 4 doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nevirapine XR 2 doses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine, low dose</intervention_name>
    <description>50 mg</description>
    <arm_group_label>Nevirapine XR 4 doses</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nevirapine, high dose</intervention_name>
    <description>100 mg</description>
    <arm_group_label>Nevirapine XR 2 doses</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male 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; values within normal&#xD;
             ranges or deviating from normal without clinical relevance as considered by the&#xD;
             investigator&#xD;
&#xD;
          -  Age ≥21 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 (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;
          -  Previous 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 30 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;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 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/1100/1100.1531_U10-1862-01.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>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/NCT02194218
org study id: 1100.1531
nct id: NCT02194218
lead sponsor: 
Study to determine the pharmacokinetic properties of 200 mg nevirapine (NVP) administered as
      4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence
      of this formulation compared to 200 mg NVP administered as 2 x 100 mg XR tablets in a single
      dose
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
time frame: up to 144 hours post-dose
measure: Maximum measured concentration of the analyte in plasma (Cmax)
time frame: up to 144 hours post-dose
measure: 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 (AUC0-tz)
time frame: up to 144 hours post-dose
measure: Time from dosing to the maximum concentration of the analyte in plasma (tmax)
time frame: up to 144 hours post-dose
measure: Terminal rate constant in plasma (λz)
time frame: up to 144 hours post-dose
measure: Terminal half-life of the analyte in plasma (t1/2)
time frame: up to 144 hours post-dose
measure: Mean residence time of the analyte in the body after po administration (MRTpo)
time frame: up to 144 hours post-dose
measure: Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
time frame: up to 144 hours post-dose
measure: Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
time frame: up to 144 hours post-dose
measure: Absorption rate constant (ka)
time frame: up to 144 hours post-dose
measure: Number of patients with adverse events
time frame: up to 35 days
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: within 8 days after last trial procedure
arm group label: Nevirapine XR 4 doses
arm group type: Experimental
arm group label: Nevirapine XR 2 doses
arm group type: Active Comparator
intervention type: Drug
intervention name: Nevirapine, low dose
description: 50 mg
arm group label: Nevirapine XR 4 doses
intervention type: Drug
intervention name: Nevirapine, high dose
description: 100 mg
arm group label: Nevirapine XR 2 doses
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1531_U10-1862-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Nevirapine