<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/NCT02250976</url>
  </required_header>
  <id_info>
    <org_study_id>HL-PIF-103</org_study_id>
    <nct_id>NCT02250976</nct_id>
  </id_info>
  <brief_title>The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca</brief_title>
  <official_title>A Clinical Trial to Evaluate the Pharmacokinetics of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca Under Fed Condition in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanlim Pharm. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanlim Pharm. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus&#xD;
      coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab.&#xD;
      2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To develop combination product of micronized fenofibrate plus pitavastatin, we would like to&#xD;
      evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized&#xD;
      fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen&#xD;
      cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed&#xD;
      condition in healthy male volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUClast(area under the curve) of fenofibric acid</measure>
    <time_frame>Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax(maximum concentration) of fenofibric acid</measure>
    <time_frame>Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast(area under the curve) of pitavastatin</measure>
    <time_frame>Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax(maximum concentration) of pitavastatin</measure>
    <time_frame>Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCinf(area under the curve) of fenofibric acid</measure>
    <time_frame>Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax(time to Maximum Plasma Concentration) of fenofibric acid</measure>
    <time_frame>Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2(half life) of fenofibric acid</measure>
    <time_frame>Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCinf(area under the curve) of pitavastatin</measure>
    <time_frame>Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax(time to Maximum Plasma Concentration) of pitavastatin</measure>
    <time_frame>Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2(half life) of pitavastatin</measure>
    <time_frame>Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, and expected period for maximum 7 days from the discharge</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Healthy Male Volunteers</condition>
  <arm_group>
    <arm_group_label>Livasupril Cap.160/2mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fenofibrate pellet ( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg&#xD;
once a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipilfen cap.160mg, Livaro tab. 2mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg&#xD;
Coadministariton of Lipilfen cap.160mg and Livaro tab. 2mg, once a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Livasupril Cap.160/2mg</intervention_name>
    <description>Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg</description>
    <arm_group_label>Livasupril Cap.160/2mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lipilfen cap. 160mg</intervention_name>
    <description>Micronized fenofibrate 160mg</description>
    <arm_group_label>Lipilfen cap.160mg, Livaro tab. 2mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Livaro tab. 2mg</intervention_name>
    <description>Pitavastatin Ca 2mg</description>
    <arm_group_label>Lipilfen cap.160mg, Livaro tab. 2mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects age 19 to 55 at the screening visit&#xD;
&#xD;
          -  Body weight≥50kg and within Ideal body weight±20%&#xD;
&#xD;
          -  Subject who is judged to be eligible according to clinical laboratory tests including&#xD;
             hematological examination, blood chemistry examination, urine analysis&#xD;
&#xD;
          -  Subject who volunteerly determined to participate in and agreed to comply with&#xD;
             precautions after totally understand the detailed explanations about this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with serious active cardiovascular, respiratory, hepatology, renal,&#xD;
             hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological&#xD;
             disease or history of such disease&#xD;
&#xD;
          -  Subject with symptoms of acute disease within 28days prior to study medication dosing&#xD;
&#xD;
          -  Subject with known for history which affect on the absorption, distribution,&#xD;
             metabolism or excretion of drug&#xD;
&#xD;
          -  Subject with clinically significant active chronic disease&#xD;
&#xD;
          -  Subject with any of the following conditions in laboratory test i. AST(aspartate&#xD;
             aminotransferase) or ALT(alanine transferase) &gt; upper normal limit × 1.5 ii. Total&#xD;
             bilirubin &gt; upper normal limit × 1.5 iii. renal failure with Creatinine clearance &lt;&#xD;
             50mL/min iv. creatine phosphokinase &gt; upper normal limit × 2&#xD;
&#xD;
          -  Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus&#xD;
             antibody, human immunodeficiency virus antigen/antibody,venereal disease research&#xD;
             laboratory test&#xD;
&#xD;
          -  Use of any prescription medication within 14 days prior to study medication dosing&#xD;
&#xD;
          -  Use of any medication such as over-the-counter medication including oriental&#xD;
             medication within 7 days prior to study medication dosing&#xD;
&#xD;
          -  Subject with clinically significant allergic disease (except for mild allergic&#xD;
             rhinitis and mild allergic dermatitis that are not needed to administer drug)&#xD;
&#xD;
          -  Subject with known for hypersensitivity reaction to fenofibrate, fenofibric acid or&#xD;
             statin&#xD;
&#xD;
          -  gallbladder disease&#xD;
&#xD;
          -  Subject who experiences photo-allergy or photo-toxicity during administrating fibrates&#xD;
             or ketoprofen&#xD;
&#xD;
          -  Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency&#xD;
             or glucose-galactose malabsorption&#xD;
&#xD;
          -  Subject who is not able to taking the institutional standard meal&#xD;
&#xD;
          -  Subject with whole blood donation within 60days, component blood donation within&#xD;
             20days&#xD;
&#xD;
          -  Subjects receiving blood transfusion within 30days prior to study medication dosing&#xD;
&#xD;
          -  Participation in any clinical investigation within 60days prior to study medication&#xD;
             dosing&#xD;
&#xD;
          -  Continued excessive use of caffeine (caffeine &gt; five cups/day),&#xD;
             alcohol(alcohol&gt;30g/day) and severe heavy smoker(cigarette &gt; 10 cigarettes per day)&#xD;
&#xD;
          -  Subjects with decision of nonparticipation through investigator's review due to&#xD;
             laboratory test results or other excuse such as non-responding to request or&#xD;
             instruction by investigator&#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>Young-Ran Yoon, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyungpook National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2018</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/NCT02250976
org study id: HL-PIF-103
nct id: NCT02250976
lead sponsor: 
has dmc: No
To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus
      coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab.
      2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.
To develop combination product of micronized fenofibrate plus pitavastatin, we would like to
      evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized
      fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen
      cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed
      condition in healthy male volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: AUClast(area under the curve) of fenofibric acid
time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)
measure: Cmax(maximum concentration) of fenofibric acid
time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)
measure: AUClast(area under the curve) of pitavastatin
time frame: Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)
measure: Cmax(maximum concentration) of pitavastatin
time frame: Pitavastatin : Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)
measure: AUCinf(area under the curve) of fenofibric acid
time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)
measure: Tmax(time to Maximum Plasma Concentration) of fenofibric acid
time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)
measure: t1/2(half life) of fenofibric acid
time frame: Pre-dose(0h), 1, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72, 96h(15 points)
measure: AUCinf(area under the curve) of pitavastatin
time frame: Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)
measure: Tmax(time to Maximum Plasma Concentration) of pitavastatin
time frame: Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)
measure: t1/2(half life) of pitavastatin
time frame: Pre-dose(0h), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 8, 12, 24, 48, 72h(18 points)
measure: Number of participants with adverse events
time frame: Participants will be followed for the duration of hospital stay, and expected period for maximum 7 days from the discharge
arm group label: Livasupril Cap.160/2mg
arm group type: Experimental
description: Fenofibrate pellet ( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
once a day
arm group label: Lipilfen cap.160mg, Livaro tab. 2mg
arm group type: Active Comparator
description: Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg
Coadministariton of Lipilfen cap.160mg and Livaro tab. 2mg, once a day
intervention type: Drug
intervention name: Livasupril Cap.160/2mg
description: Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
arm group label: Livasupril Cap.160/2mg
intervention type: Drug
intervention name: Lipilfen cap. 160mg
description: Micronized fenofibrate 160mg
arm group label: Lipilfen cap.160mg, Livaro tab. 2mg
intervention type: Drug
intervention name: Livaro tab. 2mg
description: Pitavastatin Ca 2mg
arm group label: Lipilfen cap.160mg, Livaro tab. 2mg
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Young-Ran Yoon, M.D., Ph.D.
role: Principal Investigator
affiliation: Kyungpook National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor