<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/NCT02232542</url>
  </required_header>
  <id_info>
    <org_study_id>1208.1</org_study_id>
    <nct_id>NCT02232542</nct_id>
  </id_info>
  <brief_title>Tolerability and Safety of Duloxetine BID in Healthy Female Subjects</brief_title>
  <official_title>Tolerability and Safety of 40 mg and 100 mg Duloxetine BID Given Over 7 Days in Healthy Female Subjects. A Randomised, Placebo-controlled Double-blind Trial.</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 assess the safety and tolerability of 100 mg of duloxetine BID compared to 40 mg of&#xD;
      duloxetine BID or placebo for 7 days&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2003</start_date>
  <primary_completion_date type="Actual">August 2003</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>Up to day 14 after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>Up to day 14 after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant findings in electrocardiogram (ECG)</measure>
    <time_frame>Up to day 14 after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically relevant findings in vital signs</measure>
    <time_frame>Up to day 14 after drug administration</time_frame>
    <description>systolic and diastolic blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>Up to day 14 after drug administration</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Duloxetine - low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Duloxetine - high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine - low dose</intervention_name>
    <arm_group_label>Duloxetine - low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine - high dose</intervention_name>
    <arm_group_label>Duloxetine - high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female subjects as determined by results of screening&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age ≥ 40 years&#xD;
&#xD;
          -  BMI ≥ 18.5 and ≤ 29.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding at any of the medical examinations (including blood pressure, pulse rate&#xD;
             and ECG (electrocardiogram)) deviating from normal and of clinical relevance (resting&#xD;
             heart rate greater than 100 bpm or tachyarrhythmia)&#xD;
&#xD;
          -  History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular,&#xD;
             metabolic, immunologic, hormonal disorders (except thyroid hormones and hormonal&#xD;
             replacement therapy)&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells and blackouts&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders&#xD;
&#xD;
          -  Chronic or 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, any bleeding disorder including prolonged&#xD;
             or habitual bleeding, other hematologic disease, cerebral bleeding (e.g. after a car&#xD;
             accident), commotio cerebri&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt; 24 hours) within 1 month prior to&#xD;
             administration&#xD;
&#xD;
          -  Use of any drugs that might influence the results of the trial (especially CYP2D6 or&#xD;
             CYP1A2 modulating substances) within 2 weeks prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 2 months prior to&#xD;
             administration or during trial&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from&#xD;
             smoking on study days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Caffeine abuse (&gt; 4 cups/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation within 1 month prior to administration or during the trial&#xD;
&#xD;
          -  Excessive physical activities within 10 days prior to administration or during the&#xD;
             trial&#xD;
&#xD;
          -  Any laboratory value outside the clinically accepted reference range&#xD;
&#xD;
          -  Ineffective contraception&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</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>August 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 4, 2014</last_update_submitted>
  <last_update_submitted_qc>September 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 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>Duloxetine Hydrochloride</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/NCT02232542
org study id: 1208.1
nct id: NCT02232542
lead sponsor: 
Study to assess the safety and tolerability of 100 mg of duloxetine BID compared to 40 mg of
      duloxetine BID or placebo for 7 days
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: Up to day 14 after drug administration
measure: Number of subjects with adverse events
time frame: Up to day 14 after drug administration
measure: Number of subjects with clinically relevant findings in electrocardiogram (ECG)
time frame: Up to day 14 after drug administration
measure: Number of subjects with clinically relevant findings in vital signs
time frame: Up to day 14 after drug administration
description: systolic and diastolic blood pressure
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: Up to day 14 after drug administration
arm group label: Duloxetine - low dose
arm group type: Experimental
arm group label: Duloxetine - high dose
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Duloxetine - low dose
arm group label: Duloxetine - low dose
intervention type: Drug
intervention name: Duloxetine - high dose
arm group label: Duloxetine - high dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Duloxetine Hydrochloride