<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/NCT03826485</url>
  </required_header>
  <id_info>
    <org_study_id>PRIC</org_study_id>
    <nct_id>NCT03826485</nct_id>
  </id_info>
  <brief_title>Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects</brief_title>
  <official_title>A Randomized, Open-label, Single-dose, Crossover Study to Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SamA Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SamA Pharmaceutical Co., Ltd</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is Safety, Pharmacokinetic Study of PRIC&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup&#xD;
&#xD;
        2. To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 25, 2019</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>Area Under the Curve (AUC) to last time point (t)</measure>
    <time_frame>0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose</time_frame>
    <description>Area under the PRIC/Pranlukast dry syrup concentration in blood-time curve from zero to the final</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration of drug (Cmax)</measure>
    <time_frame>0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose</time_frame>
    <description>The maximum PRIC/Pranlukast dry syrup concentration in blood sampling time t</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>A group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1: PRIC Period 2: Pranlukast hydrate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1: Pranlukast hydrate Period 2: PRIC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRIC</intervention_name>
    <description>Pranlukast hydrate 50mg</description>
    <arm_group_label>A group</arm_group_label>
    <arm_group_label>B group</arm_group_label>
    <other_name>PRIC 50mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pranlukast hydrate</intervention_name>
    <description>Pranlukast hydrate 225mg/2.25g</description>
    <arm_group_label>A group</arm_group_label>
    <arm_group_label>B group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  19 to 45 years old healthy male subject at the screening&#xD;
&#xD;
          -  Subject who is able to provide written informed consent and decided on his own&#xD;
             participation after understanding fully to hear a detailed explanation in the clinical&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or&#xD;
             glucose-galactose malabsorption etc.&#xD;
&#xD;
          -  Subjects with history of clinically significant allergy, cardiovascular, peripheral&#xD;
             vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory,&#xD;
             musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal,&#xD;
             genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other&#xD;
             conditions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Songpa-gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Hyung Suk Lim, MD, Ph.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pranlukast hydrate</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pranlukast</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03826485
org study id: PRIC
nct id: NCT03826485
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is Safety, Pharmacokinetic Study of PRIC
1. To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup

        2. To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Curve (AUC) to last time point (t)
time frame: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
description: Area under the PRIC/Pranlukast dry syrup concentration in blood-time curve from zero to the final
measure: Maximum concentration of drug (Cmax)
time frame: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
description: The maximum PRIC/Pranlukast dry syrup concentration in blood sampling time t
arm group label: A group
arm group type: Experimental
description: Period 1: PRIC Period 2: Pranlukast hydrate
arm group label: B group
arm group type: Experimental
description: Period 1: Pranlukast hydrate Period 2: PRIC
intervention type: Drug
intervention name: PRIC
description: Pranlukast hydrate 50mg
arm group label: A group
arm group label: B group
other name: PRIC 50mg
intervention type: Drug
intervention name: Pranlukast hydrate
description: Pranlukast hydrate 225mg/2.25g
arm group label: A group
arm group label: B group
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pranlukast
sharing ipd: No