<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/NCT02183259</url>
  </required_header>
  <id_info>
    <org_study_id>1172.1</org_study_id>
    <nct_id>NCT02183259</nct_id>
  </id_info>
  <brief_title>Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL in Healthy Adult Male Volunteers</brief_title>
  <official_title>Absolute Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL 1 mg Capsule Compared to 0.015 mg Solution i.v. as Single Administration in Healthy Male Subjects (Open-labelled, 2-way Cross-over 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>
      To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma&#xD;
      concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to&#xD;
      healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150&#xD;
      CL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 1998</start_date>
  <primary_completion_date type="Actual">December 1998</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma drug concentration-time curve from time zero to infinity</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>maximum drug plasma concentration (Cmax)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>time to achieve maximum drug plasma concentration (tmax)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>elimination half-life (t1/2)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>mean residence time (MRT)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>total clearance (CL)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of adverse events</measure>
    <time_frame>up to day 22</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>ESR 1150 CL capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>ESR 1150 CL ampoule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ESR 1150 CL, Capsule, oral</intervention_name>
    <arm_group_label>ESR 1150 CL capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ESR 1150 CL, solution, intravenous</intervention_name>
    <arm_group_label>ESR 1150 CL ampoule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy male subjects&#xD;
&#xD;
          -  age: &gt;= 20 and &lt;= 35 years&#xD;
&#xD;
          -  weight: &gt;= 50 to &lt;= 80 kg and within +/- 20 % of standard weight&#xD;
&#xD;
          -  blood pressure: systolic 100 - 138 mmHg and diastolic of less than 84 mmHg&#xD;
&#xD;
          -  pulse rate: 45 to 80 beat/min&#xD;
&#xD;
          -  volunteer whose participation in the trial is judged valid by the investigator based&#xD;
             on the results of preliminary check-up and pre-administration check-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal&#xD;
             disease&#xD;
&#xD;
          -  history of drug allergy&#xD;
&#xD;
          -  history of drug dependency, alcohol dependency, etc.&#xD;
&#xD;
          -  use of other trial drug within 6 months before study drug administration&#xD;
&#xD;
          -  use of any drugs within 7 days before study drug administration&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 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/1172/1172.1_U01-3294.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02183259
org study id: 1172.1
nct id: NCT02183259
lead sponsor: 
To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma
      concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to
      healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150
      CL.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the plasma drug concentration-time curve from time zero to infinity
time frame: up to 16 hours after drug administration
measure: maximum drug plasma concentration (Cmax)
time frame: up to 16 hours after drug administration
measure: time to achieve maximum drug plasma concentration (tmax)
time frame: up to 16 hours after drug administration
measure: elimination half-life (t1/2)
time frame: up to 16 hours after drug administration
measure: mean residence time (MRT)
time frame: up to 16 hours after drug administration
measure: total clearance (CL)
time frame: up to 16 hours after drug administration
measure: number of adverse events
time frame: up to day 22
arm group label: ESR 1150 CL capsule
arm group type: Experimental
arm group label: ESR 1150 CL ampoule
arm group type: Experimental
intervention type: Drug
intervention name: ESR 1150 CL, Capsule, oral
arm group label: ESR 1150 CL capsule
intervention type: Drug
intervention name: ESR 1150 CL, solution, intravenous
arm group label: ESR 1150 CL ampoule
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1172/1172.1_U01-3294.pdf
description: Related Info
responsible party type: Sponsor