<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/NCT03240939</url>
  </required_header>
  <id_info>
    <org_study_id>YY-201_PK</org_study_id>
    <nct_id>NCT03240939</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil</brief_title>
  <official_title>A Randomized, Open Label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil Administered in Healthy Male Volunteer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuyu Pharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuyu Pharma, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, open label, single dose, two-way crossover clinical trial to investigate the&#xD;
      pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil&#xD;
      administered in healthy male volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Actual">October 10, 2017</completion_date>
  <primary_completion_date type="Actual">July 7, 2017</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)</time_frame>
    <description>&quot;Peak Plasma Concentration&quot; of Dutasteride, tadalafil</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)</time_frame>
    <description>Time at which the maximum concentration of Dutasteride, Tadalafil</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2β</measure>
    <time_frame>Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)</time_frame>
    <description>half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCinf</measure>
    <time_frame>Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)</time_frame>
    <description>area under the plasma concentration versus time curve of Dutasteride, Tadalafil</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Benign Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Dutasteride&amp;Tadalafil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YY-201</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>YY-201 capsule, singe dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dutasteride 0.5 mg</intervention_name>
    <description>single dose</description>
    <arm_group_label>Dutasteride&amp;Tadalafil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil 5 mg</intervention_name>
    <description>single dose</description>
    <arm_group_label>Dutasteride&amp;Tadalafil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>YY-201</intervention_name>
    <description>single dose</description>
    <arm_group_label>YY-201</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19 to 45 years&#xD;
&#xD;
          -  BMI score 19 kg/m2 to 28 kg/m2&#xD;
&#xD;
          -  SBP &lt; 140 mmHg and ≤ 90 mmHg or DBP &lt; 90 mmHg and ≥ 50 mmHg&#xD;
&#xD;
          -  Eligible according to the laboratory results of hematology, blood chemistry and&#xD;
             urinalysis&#xD;
&#xD;
          -  Voluntarily signed the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastrointestinal diseases or surgery which may affect absorption of the&#xD;
             investigational products within 6 months&#xD;
&#xD;
          -  History of hypersensitivity&#xD;
&#xD;
          -  history of Cardiovascular disease&#xD;
&#xD;
          -  History of degenerative Retina disease&#xD;
&#xD;
          -  Lactose intolerance&#xD;
&#xD;
          -  Medical history of vision loss&#xD;
&#xD;
          -  Clinically significant disorders of allergy, drug hypersensitivity reaction,&#xD;
             hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine,&#xD;
             dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology,&#xD;
             otorhinolaryngology, and cardiovascular system&#xD;
&#xD;
          -  Donated whole blood (transfusion, apheresis etc..) within 60 days&#xD;
&#xD;
          -  Participated and administered the investigational products in other clinical trial&#xD;
             within 90 days&#xD;
&#xD;
          -  Taking drugs which may affect Clinical trial within 30 days&#xD;
&#xD;
          -  Smoked more than 10 cigarettes a day for past 30 days&#xD;
&#xD;
          -  Excessive alcohol consumption (&gt; 3 units/week, 1 unit)&#xD;
&#xD;
          -  Taking food which may affect Clinical trial within 7 days&#xD;
&#xD;
          -  Positive result from Urinary test&#xD;
&#xD;
          -  Positive result from Serum test&#xD;
&#xD;
          -  Clinically significant disorders result from Electrocardiography test&#xD;
&#xD;
          -  Not eligible due to investigator's judgments&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyeong-Seok Lim, M.D.,Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>April 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>November 21, 2017</last_update_submitted>
  <last_update_submitted_qc>November 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dutasteride</keyword>
  <keyword>Tadalafil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Dutasteride</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/NCT03240939
org study id: YY-201_PK
nct id: NCT03240939
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A randomized, open label, single dose, two-way crossover clinical trial to investigate the
      pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil
      administered in healthy male volunteers
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Cmax
time frame: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
description: "Peak Plasma Concentration" of Dutasteride, tadalafil
measure: Tmax
time frame: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
description: Time at which the maximum concentration of Dutasteride, Tadalafil
measure: t1/2β
time frame: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
description: half-life
measure: AUCinf
time frame: Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)
description: area under the plasma concentration versus time curve of Dutasteride, Tadalafil
arm group label: Dutasteride&Tadalafil
arm group type: Active Comparator
description: Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose
arm group label: YY-201
arm group type: Experimental
description: YY-201 capsule, singe dose
intervention type: Drug
intervention name: Dutasteride 0.5 mg
description: single dose
arm group label: Dutasteride&Tadalafil
intervention type: Drug
intervention name: Tadalafil 5 mg
description: single dose
arm group label: Dutasteride&Tadalafil
intervention type: Drug
intervention name: YY-201
description: single dose
arm group label: YY-201
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hyeong-Seok Lim, M.D.,Ph.D.
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Tadalafil
mesh term: Dutasteride