<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/NCT03802526</url>
  </required_header>
  <id_info>
    <org_study_id>NVP-1805_DDI</org_study_id>
    <nct_id>NCT03802526</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2</brief_title>
  <official_title>Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NVP Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NVP Healthcare</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 to compare the pharmacokinetics and safety/tolerability between&#xD;
      NVP-1805-R1 and NVP-1805-R2&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2019</start_date>
  <completion_date type="Actual">September 27, 2019</completion_date>
  <primary_completion_date type="Actual">July 4, 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>Pharmacokinetic interaction</measure>
    <time_frame>0hours - 48hours</time_frame>
    <description>Area under the curve (AUC)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>NVP-1805-R1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: NVP-1805-R1&#xD;
1 tablet, oral dosing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP-1805-R2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: NVP-1805-R2&#xD;
1 tablet, oral dosing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NVP-1805-R1 and NVP-1805-R2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP-1805-R1</intervention_name>
    <description>1 tablet, multiple oral dosing</description>
    <arm_group_label>NVP-1805-R1</arm_group_label>
    <other_name>NVP-1805-R1(M)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP-1805-R2</intervention_name>
    <description>1 tablet, multiple oral dosing</description>
    <arm_group_label>NVP-1805-R2</arm_group_label>
    <other_name>NVP-1805-R2(C)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVP-1805-R1 and NVP-1805-R2</intervention_name>
    <description>NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing</description>
    <arm_group_label>NVP-1805-R1 and NVP-1805-R2</arm_group_label>
    <other_name>NVP-1805-R1(M) and NVP-1805-R2(C)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female adults aged 19-45 years.&#xD;
&#xD;
          -  BMI of &gt;18.5 kg/㎡ and &lt;27.0 kg/㎡ subject, weight more than 50kg.&#xD;
&#xD;
          -  Voluntarily provided a witten consent to participate in this clinical study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with an investigational product (Phase I study or Biological study) within&#xD;
             3month preceeding the first dose of study medication.&#xD;
&#xD;
          -  History of (or presence) study medication absortion, distribution, metabolism(e.g.,&#xD;
             liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology,&#xD;
             oncology, CNS, musculo-skeletal) or related past medical/surgery history&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Dong Sung Shin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gachon University Gil Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Navipharm</name>
      <address>
        <city>Suwon-si</city>
        <state>Gyeonggi-do</state>
        <zip>16209</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>November 26, 2019</last_update_submitted>
  <last_update_submitted_qc>November 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03802526
org study id: NVP-1805_DDI
nct id: NCT03802526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between
      NVP-1805-R1 and NVP-1805-R2
pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic interaction
time frame: 0hours - 48hours
description: Area under the curve (AUC)
arm group label: NVP-1805-R1
arm group type: Experimental
description: Drug: NVP-1805-R1
1 tablet, oral dosing
arm group label: NVP-1805-R2
arm group type: Experimental
description: Drug: NVP-1805-R2
1 tablet, oral dosing
arm group label: NVP-1805-R1 and NVP-1805-R2
arm group type: Experimental
description: Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing)
intervention type: Drug
intervention name: NVP-1805-R1
description: 1 tablet, multiple oral dosing
arm group label: NVP-1805-R1
other name: NVP-1805-R1(M)
intervention type: Drug
intervention name: NVP-1805-R2
description: 1 tablet, multiple oral dosing
arm group label: NVP-1805-R2
other name: NVP-1805-R2(C)
intervention type: Drug
intervention name: NVP-1805-R1 and NVP-1805-R2
description: NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing
arm group label: NVP-1805-R1 and NVP-1805-R2
other name: NVP-1805-R1(M) and NVP-1805-R2(C)
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dong Sung Shin, M.D.
role: Principal Investigator
affiliation: Gachon University Gil Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: No