<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/NCT02247505</url>
  </required_header>
  <id_info>
    <org_study_id>150DDI14013</org_study_id>
    <nct_id>NCT02247505</nct_id>
  </id_info>
  <brief_title>CKD-397 Drug-drug Interaction Study (B)</brief_title>
  <acronym>CKD-397DDI(B)</acronym>
  <official_title>A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Pharmacokinetic Effect of Tadalafil on Tamsulosin in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate to effect of tadalafil on the pharmacokinetic&#xD;
      properies of tamsulosin&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate&#xD;
      the pharmacokinetic effect of tadalafil(5mg) on tamsulosin(0.2mg) in healthy male subjects&#xD;
      Subjects will receive repeated dose of tamsulosin (0.2mg*1t/day) or tamsulosin (0.2mg*1t/day)&#xD;
      / tadalafil (5mg*1t/day) for 5days Each treatment period was separated by a washout period of&#xD;
      at least 10 days. Each period of study will enroll 14 healthy male subjects. Blood samples&#xD;
      for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be&#xD;
      assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of&#xD;
      adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 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>Tamsulosin AUCt(0-24)</measure>
    <time_frame>1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tamsulosin Cmax</measure>
    <time_frame>1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tamsulosin Css,min</measure>
    <time_frame>1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tamsulosin Css,av</measure>
    <time_frame>1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tamsulosin Tss,max</measure>
    <time_frame>1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tamsulosin t1/2</measure>
    <time_frame>1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tamsulosin CL/F</measure>
    <time_frame>1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tamsulosin Vd/F</measure>
    <time_frame>1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tamsulosin fluctuation[(Css,max-Css,min)/Css,av]</measure>
    <time_frame>1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tamsulosin swing[(Css,max-Css,min)/Css,min]</measure>
    <time_frame>1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Healty Male Volunteers</condition>
  <arm_group>
    <arm_group_label>Group1: Treatment A + Treatment B, PO</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment A : Tamsulosin 0.2mg*1t for 5days, Treatment B : Tamsulosin 0.2mg*1t/day and Tadalafil 5mg*1t/day for 5days, Each treatment period was separated by a washout period of at least 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group2: Treatment B + Treatment A, PO</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment A : Tamsulosin 0.2mg*1t for 5days, Treatment B : Tamsulosin 0.2mg*1t/day and Tadalafil 5mg*1t/day for 5days, Each treatment period was separated by a washout period of at least 10 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Harnal-D Cap. 0.2mg</intervention_name>
    <arm_group_label>Group1: Treatment A + Treatment B, PO</arm_group_label>
    <arm_group_label>Group2: Treatment B + Treatment A, PO</arm_group_label>
    <other_name>Tamsulosin 0.2mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cialis Tab. 5mg</intervention_name>
    <arm_group_label>Group1: Treatment A + Treatment B, PO</arm_group_label>
    <arm_group_label>Group2: Treatment B + Treatment A, PO</arm_group_label>
    <other_name>Tadalafil 5mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy man age 19 years or more and less than 55 years old at the time of screening.&#xD;
&#xD;
          -  BMI more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 55kg&#xD;
&#xD;
          -  Subject without congenital or chronic diseases and no psychotic symptoms or findings&#xD;
             from the medical examination.&#xD;
&#xD;
          -  Suitable subject who is determined by laboratory tests such as hematology tests, blood&#xD;
             chemistry, urinalysis test according to the characteristics of the drug and screening&#xD;
             tests such as ECG test.&#xD;
&#xD;
          -  Subject who fully understand the clinical trials after in-depth explanation given&#xD;
             prior to the clinical study, decided to join the clinical trials by their will and&#xD;
             signed consent form which approved by Chonbuk National University Hospital IRB.&#xD;
&#xD;
          -  Subjects who are able to comply with all scheduled visits, laboratory tests and other&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal,&#xD;
             urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that&#xD;
             is clinically significant (Except untreated asymptomatic seasonal allergies at the&#xD;
             time of administration)&#xD;
&#xD;
          -  Subject who has a history of gastrointestinal disease or gastrointestinal surgery&#xD;
             which can affect drug absorption.&#xD;
&#xD;
          -  Showing the value that corresponds to following laboratory parameters: AST or AST &gt; 2*&#xD;
             upper limit of normal range.&#xD;
&#xD;
          -  Alcohol &gt; 210g/week, within 6 months prior to the screening.&#xD;
&#xD;
          -  Taking the medication involved in other clinical trials within two months before the&#xD;
             first dose medication characters.&#xD;
&#xD;
          -  Sitting Systolic Blood Pressure ≥ 140 mmHg, Diastolic Blood Pressure ≥ 90 mmHg at the&#xD;
             time of screening.&#xD;
&#xD;
          -  History of alcohol or drug abuse, within 1 year&#xD;
&#xD;
          -  Positive result in urine drug test(Amphetamines, Cocaine, Opioid, Benzodiazepines,&#xD;
             Cannabinoid)&#xD;
&#xD;
          -  Positive result in Serology test(Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency&#xD;
             Virus), TPPA(qual)).&#xD;
&#xD;
          -  Subject who takes an abnormal meal which can affect the ADME of drug.&#xD;
&#xD;
          -  Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals&#xD;
             within 30days prior to the first dosing.&#xD;
&#xD;
          -  Smoker (&gt; 20cigarettes/day)&#xD;
&#xD;
          -  Subjects who takes ETC or OTC medicine within 10days before the first IP&#xD;
             administration.&#xD;
&#xD;
          -  Subject who done the whole blood donation within two months or component blood&#xD;
             donation within 1 month prior to the first dosing.&#xD;
&#xD;
          -  Subject who can increase risk due to clinical test and administration of drugs or has&#xD;
             Severe grade / chronic medical, mental condition or abnormal laboratory result that&#xD;
             may interfere with the analysis of test results.&#xD;
&#xD;
          -  Subject with taking any forms of organic nitrate periodically and/or intermittently.&#xD;
&#xD;
          -  Subject with known hereditary degenerative retinal disease including retinitis&#xD;
             pigmentosa.&#xD;
&#xD;
          -  Subject with serious history of hypersensitivity or allergy to investigational&#xD;
             product.&#xD;
&#xD;
          -  Subject who Lost sight of one eye by Non-arteritic anterior ischemic optic neuropathy&#xD;
             (NAION).&#xD;
&#xD;
          -  Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency,&#xD;
             glucose-galactose malabsorption.&#xD;
&#xD;
          -  Orthostatic hypotension&#xD;
&#xD;
          -  Subjects who is not able to comply with guidelines described in the protocol.&#xD;
&#xD;
          -  Subjects who is determined by investigator's decision as unsuitable for clinical trial&#xD;
             participation.&#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>
  <overall_official>
    <last_name>Min Gul Kim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>August 19, 2015</last_update_submitted>
  <last_update_submitted_qc>August 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2015</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>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/NCT02247505
org study id: 150DDI14013
nct id: NCT02247505
lead sponsor: 
has dmc: No
The purpose of this study is to investigate to effect of tadalafil on the pharmacokinetic
      properies of tamsulosin
This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate
      the pharmacokinetic effect of tadalafil(5mg) on tamsulosin(0.2mg) in healthy male subjects
      Subjects will receive repeated dose of tamsulosin (0.2mg*1t/day) or tamsulosin (0.2mg*1t/day)
      / tadalafil (5mg*1t/day) for 5days Each treatment period was separated by a washout period of
      at least 10 days. Each period of study will enroll 14 healthy male subjects. Blood samples
      for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be
      assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of
      adverse events.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tamsulosin AUCt(0-24)
time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
measure: Tamsulosin Cmax
time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
measure: Tamsulosin Css,min
time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
measure: Tamsulosin Css,av
time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
measure: Tamsulosin Tss,max
time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
measure: Tamsulosin t1/2
time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
measure: Tamsulosin CL/F
time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
measure: Tamsulosin Vd/F
time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
measure: Tamsulosin fluctuation[(Css,max-Css,min)/Css,av]
time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
measure: Tamsulosin swing[(Css,max-Css,min)/Css,min]
time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h
arm group label: Group1: Treatment A + Treatment B, PO
arm group type: Other
description: Treatment A : Tamsulosin 0.2mg*1t for 5days, Treatment B : Tamsulosin 0.2mg*1t/day and Tadalafil 5mg*1t/day for 5days, Each treatment period was separated by a washout period of at least 10 days.
arm group label: Group2: Treatment B + Treatment A, PO
arm group type: Other
description: Treatment A : Tamsulosin 0.2mg*1t for 5days, Treatment B : Tamsulosin 0.2mg*1t/day and Tadalafil 5mg*1t/day for 5days, Each treatment period was separated by a washout period of at least 10 days.
intervention type: Drug
intervention name: Harnal-D Cap. 0.2mg
arm group label: Group1: Treatment A + Treatment B, PO
arm group label: Group2: Treatment B + Treatment A, PO
other name: Tamsulosin 0.2mg
intervention type: Drug
intervention name: Cialis Tab. 5mg
arm group label: Group1: Treatment A + Treatment B, PO
arm group label: Group2: Treatment B + Treatment A, PO
other name: Tadalafil 5mg
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Min Gul Kim, PhD
role: Principal Investigator
affiliation: Chonbuk National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Tadalafil
mesh term: Tamsulosin