<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/NCT02239484</url>
  </required_header>
  <id_info>
    <org_study_id>HM-TASU-101</org_study_id>
    <nct_id>NCT02239484</nct_id>
  </id_info>
  <brief_title>Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin</brief_title>
  <official_title>An Open-label, Randomized, Multiple-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanmi Pharmaceutical Company Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanmi Pharmaceutical Company Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and&#xD;
      Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and both&#xD;
      together in a 3 period repeatedly.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Tadalafil,Tamsulosin Cmax,ss</measure>
    <time_frame>6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tadalafil,Tamsulosin AUCτ</measure>
    <time_frame>6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tadalafil,Tamsulosin tmax,ss</measure>
    <time_frame>6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tadalafil,Tamsulosin t1/2</measure>
    <time_frame>6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tadalafil,Tamsulosin CL/Fss</measure>
    <time_frame>6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tadalafil,Tamsulosin Vd/Fss</measure>
    <time_frame>6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tadalafil,Tamsulosin Cav</measure>
    <time_frame>6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tadalafil,Tamsulosin Cmin,ss</measure>
    <time_frame>6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Erectile Dysfunction</condition>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tadalafil→Tamsulosin→Tadalafil+Tamsulosin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tadalafil+Tamsulosin→Tadalafil→Tamsulosin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tamsulosin→Tadalafil+Tamsulosin→Tadalafil</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil</intervention_name>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin</intervention_name>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil + Tamsulosin</intervention_name>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male volunteers, age 20 to 55 years.&#xD;
&#xD;
          2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2&#xD;
&#xD;
          3. Subjects who have ability to comprehend the objectives, contents of study and property&#xD;
             of study drug before participating in trial and have willingness to sign of informed&#xD;
             consent in writing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of medical history or a concurrent disease that may interfere with treatment&#xD;
             and safety assessment or completion of this clinical study, including clinically&#xD;
             significant disorders in kidney, liver, cardiovascular system, respiratory system,&#xD;
             endocrine system, or neuropsychiatric system.&#xD;
&#xD;
          2. Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal&#xD;
             range.&#xD;
&#xD;
          3. Systolic blood pressure &lt;90mmHg or Diastolic blood pressure &lt; 70 mmHg, systolic blood&#xD;
             pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure)&#xD;
             during the screening procedure.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samgsung Seoul Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tadalafil</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/NCT02239484
org study id: HM-TASU-101
nct id: NCT02239484
lead sponsor: 
has dmc: No
We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and
      Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and both
      together in a 3 period repeatedly.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tadalafil,Tamsulosin Cmax,ss
time frame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin AUCτ
time frame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin tmax,ss
time frame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin t1/2
time frame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin CL/Fss
time frame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin Vd/Fss
time frame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin Cav
time frame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin Cmin,ss
time frame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
arm group label: Sequence 1
arm group type: Experimental
description: Tadalafil→Tamsulosin→Tadalafil+Tamsulosin
arm group label: Sequence 2
arm group type: Experimental
description: Tadalafil+Tamsulosin→Tadalafil→Tamsulosin
arm group label: Sequence 3
arm group type: Experimental
description: Tamsulosin→Tadalafil+Tamsulosin→Tadalafil
intervention type: Drug
intervention name: Tadalafil
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
intervention type: Drug
intervention name: Tamsulosin
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
intervention type: Drug
intervention name: Tadalafil + Tamsulosin
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Erectile Dysfunction
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Tadalafil
mesh term: Tamsulosin