<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/NCT02264184</url>
  </required_header>
  <id_info>
    <org_study_id>527.79</org_study_id>
    <nct_id>NCT02264184</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Pharmacokinetics of Tamsulosin in Healthy Male Volunteers</brief_title>
  <official_title>An Open Label Randomized Two-way Crossover Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Single Oral Dose Pharmacokinetics of Tamsulosin in Healthy Male Volunteers (CYP2D6 Extensive Metabolizers)</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 effect of CYP2D6 inhibition by paroxetine on the single oral dose&#xD;
      pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <primary_completion_date type="Actual">December 2008</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 measured concentration of tamsulosin HCl in plasma)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞ (area under the concentration-time curve of tamsulosin HCl in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum measured concentration of tamsulosin HCl in plasma)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of tamsulosin HCl in plasma over the time interval from 0 to the last quantifiable data point)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant of tamsulosin HCl in plasma)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of tamsulosin HCl in plasma)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of tamsulosin HCl in the body after oral administration)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of tamsulosin HCl in plasma after an extravascular administration)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution of tamsulosin HCl during the terminal phase λz following an extravascular administration)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RCmax,T/R (ratio of the Cmax value of the test treatment to the Cmax value of the reference treatment after single dose)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RAUC0-∞,T/R (ratio of the test treatment versus the reference treatment from zero to infinity, expressed as ratio of AUC values after single dose)</measure>
    <time_frame>up to 48 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 21 days after last treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>within 21 days after last treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Tamsulosin + Paroxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tamsulosin: q.d on day 1&#xD;
Paroxetine: higher dose q.d. on days -7 to 2 q.d., lower dose on days -10 to -8 and 3 to 5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tamsulosin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tamsulosin: q.d on day 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin</intervention_name>
    <arm_group_label>Tamsulosin</arm_group_label>
    <arm_group_label>Tamsulosin + Paroxetine</arm_group_label>
    <other_name>Alna®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paroxetine</intervention_name>
    <arm_group_label>Tamsulosin + Paroxetine</arm_group_label>
    <other_name>Tagonis®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants in the study are&#xD;
&#xD;
          -  Healthy males&#xD;
&#xD;
          -  Ranging from 21 to 50 years of age&#xD;
&#xD;
          -  Body mass index (BMI) within 18.5 to 29.9 kg/m2&#xD;
&#xD;
          -  In accordance with Good Clinical Practice (GCP) and the local legislation all&#xD;
             volunteers will have given their written informed consent prior to admission to the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders, clinically relevant electrolyte disturbances&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or clinically relevant acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24:00 hours) within at least one month or&#xD;
             less than ten half-lives of the respective drug before enrolment in the study or&#xD;
             during the study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial up to 7 days prior to&#xD;
             enrolment in the study or during the study&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (within two months prior&#xD;
             to administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars of &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (&gt; 100 mL within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range if indicative of underlying disease&#xD;
             or poor health&#xD;
&#xD;
          -  Excessive physical activities within the last week before the trial or during the&#xD;
             trial&#xD;
&#xD;
          -  Hypersensitivity to treatment medication and/or related drugs of these classes&#xD;
&#xD;
          -  Non extensive metabolizer (EM) for CYP2D6&#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</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 14, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 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>Paroxetine</mesh_term>
    <mesh_term>Tamsulosin</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/NCT02264184
org study id: 527.79
nct id: NCT02264184
lead sponsor: 
Study to investigate the effect of CYP2D6 inhibition by paroxetine on the single oral dose
      pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (maximum measured concentration of tamsulosin HCl in plasma)
time frame: up to 48 hours after dosing
measure: AUC0-∞ (area under the concentration-time curve of tamsulosin HCl in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 48 hours after dosing
measure: tmax (time from dosing to the maximum measured concentration of tamsulosin HCl in plasma)
time frame: up to 48 hours after dosing
measure: AUC0-tz (area under the concentration-time curve of tamsulosin HCl in plasma over the time interval from 0 to the last quantifiable data point)
time frame: up to 48 hours after dosing
measure: λz (terminal rate constant of tamsulosin HCl in plasma)
time frame: up to 48 hours after dosing
measure: t1/2 (terminal half-life of tamsulosin HCl in plasma)
time frame: up to 48 hours after dosing
measure: MRTpo (mean residence time of tamsulosin HCl in the body after oral administration)
time frame: up to 48 hours after dosing
measure: CL/F (apparent clearance of tamsulosin HCl in plasma after an extravascular administration)
time frame: up to 48 hours after dosing
measure: Vz/F (apparent volume of distribution of tamsulosin HCl during the terminal phase λz following an extravascular administration)
time frame: up to 48 hours after dosing
measure: RCmax,T/R (ratio of the Cmax value of the test treatment to the Cmax value of the reference treatment after single dose)
time frame: up to 48 hours after dosing
measure: RAUC0-∞,T/R (ratio of the test treatment versus the reference treatment from zero to infinity, expressed as ratio of AUC values after single dose)
time frame: up to 48 hours after dosing
measure: Number of subjects with adverse events
time frame: up to 21 days after last treatment
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: within 21 days after last treatment
arm group label: Tamsulosin + Paroxetine
arm group type: Experimental
description: Tamsulosin: q.d on day 1
Paroxetine: higher dose q.d. on days -7 to 2 q.d., lower dose on days -10 to -8 and 3 to 5
arm group label: Tamsulosin
arm group type: Active Comparator
description: Tamsulosin: q.d on day 1
intervention type: Drug
intervention name: Tamsulosin
arm group label: Tamsulosin
arm group label: Tamsulosin + Paroxetine
other name: Alna®
intervention type: Drug
intervention name: Paroxetine
arm group label: Tamsulosin + Paroxetine
other name: Tagonis®
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Paroxetine
mesh term: Tamsulosin