<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/NCT04477369</url>
  </required_header>
  <id_info>
    <org_study_id>DW_DWJ1464101</org_study_id>
    <nct_id>NCT04477369</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers</brief_title>
  <official_title>An Exploratory Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daewoong Pharmaceutical Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daewoong 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 to explore the differences in pharmacokinetics and safety&#xD;
      characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003,&#xD;
      DWC202004) in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to explore the differences in pharmacokinetics and safety&#xD;
      characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003,&#xD;
      DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose,&#xD;
      four-treatment, three-period, non-replicated crossover study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 6, 2020</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</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>PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Area under the plasma concentration-time curve from time 0 to time t</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Maximum plasma drug concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Area under the plasma concentration-time curve from time 0 to time t</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Maximum plasma drug concentration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Area under the plasma concentration-time curve from drug administration to drug elimination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Time to reach maximum plasma concentration following drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Elimination half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Apparent total clearance of drug from plasma after oral administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Apparent volume of distribution after oral administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Area under the plasma concentration-time curve from drug administration to drug elimination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Time to reach maximum plasma concentration following drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Elimination half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Apparent total clearance of drug from plasma after oral administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F</measure>
    <time_frame>0 - 72 hours after dosing</time_frame>
    <description>Apparent volume of distribution after oral administration</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sequence A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence C</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence D</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWJ1439</intervention_name>
    <description>300mg single dose</description>
    <arm_group_label>Sequence A</arm_group_label>
    <arm_group_label>Sequence C</arm_group_label>
    <arm_group_label>Sequence D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWJ1464</intervention_name>
    <description>300mg single dose</description>
    <arm_group_label>Sequence A</arm_group_label>
    <arm_group_label>Sequence B</arm_group_label>
    <arm_group_label>Sequence D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWC202003</intervention_name>
    <description>300mg single dose</description>
    <arm_group_label>Sequence A</arm_group_label>
    <arm_group_label>Sequence B</arm_group_label>
    <arm_group_label>Sequence C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWC202004</intervention_name>
    <description>300mg single dose</description>
    <arm_group_label>Sequence B</arm_group_label>
    <arm_group_label>Sequence C</arm_group_label>
    <arm_group_label>Sequence D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult volunteers aged 19 years old to under 55.&#xD;
&#xD;
          -  BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg&#xD;
&#xD;
          -  Those who have no congenital or chronic disease requiring treatment and have no&#xD;
             pathological symptoms or findings as a result of medical examination.&#xD;
&#xD;
          -  Those who have no clinically significant abnormalities in general physical&#xD;
             examination, laboratory assessments and 12-lead electrocardiogram (ECG).&#xD;
&#xD;
          -  Those who understand the requirements of the study and sign a written informed&#xD;
             consent, and also accept all the restrictions imposed during the course of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history or presence of any clinically significant medical condition.&#xD;
&#xD;
          -  Participation in a clinical drug study or bioequivalence study 6 months prior to the&#xD;
             present study.&#xD;
&#xD;
          -  Refusal to abstain from smoking or consumption of tobacco products 72 hours before&#xD;
             drug administration and during each study period.&#xD;
&#xD;
          -  Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit&#xD;
             containing food or drinks for 72 hours before drug administration and during each&#xD;
             study period.&#xD;
&#xD;
          -  Refusal to abstain from strenuous activities for 72 hours before drug administration&#xD;
             and post-study visit, before and during each study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bo-Hyung Kim</last_name>
    <phone>+82-2-958-9326</phone>
    <email>bhkim98@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kyung Hee University Medical Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bo-Hyung Kim</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</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/NCT04477369
org study id: DW_DWJ1464101
nct id: NCT04477369
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the differences in pharmacokinetics and safety
      characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003,
      DWC202004) in healthy adults.
The purpose of this study is to explore the differences in pharmacokinetics and safety
      characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003,
      DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose,
      four-treatment, three-period, non-replicated crossover study
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t
time frame: 0 - 72 hours after dosing
description: Area under the plasma concentration-time curve from time 0 to time t
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax
time frame: 0 - 72 hours after dosing
description: Maximum plasma drug concentration
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t
time frame: 0 - 72 hours after dosing
description: Area under the plasma concentration-time curve from time 0 to time t
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax
time frame: 0 - 72 hours after dosing
description: Maximum plasma drug concentration
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf
time frame: 0 - 72 hours after dosing
description: Area under the plasma concentration-time curve from drug administration to drug elimination
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax
time frame: 0 - 72 hours after dosing
description: Time to reach maximum plasma concentration following drug administration
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2
time frame: 0 - 72 hours after dosing
description: Elimination half-life
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F
time frame: 0 - 72 hours after dosing
description: Apparent total clearance of drug from plasma after oral administration
measure: PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F
time frame: 0 - 72 hours after dosing
description: Apparent volume of distribution after oral administration
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf
time frame: 0 - 72 hours after dosing
description: Area under the plasma concentration-time curve from drug administration to drug elimination
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax
time frame: 0 - 72 hours after dosing
description: Time to reach maximum plasma concentration following drug administration
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2
time frame: 0 - 72 hours after dosing
description: Elimination half-life
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F
time frame: 0 - 72 hours after dosing
description: Apparent total clearance of drug from plasma after oral administration
measure: PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F
time frame: 0 - 72 hours after dosing
description: Apparent volume of distribution after oral administration
arm group label: Sequence A
arm group type: Other
description: 7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.
arm group label: Sequence B
arm group type: Other
description: 7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.
arm group label: Sequence C
arm group type: Other
description: 7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.
arm group label: Sequence D
arm group type: Other
description: 7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.
intervention type: Drug
intervention name: DWJ1439
description: 300mg single dose
arm group label: Sequence A
arm group label: Sequence C
arm group label: Sequence D
intervention type: Drug
intervention name: DWJ1464
description: 300mg single dose
arm group label: Sequence A
arm group label: Sequence B
arm group label: Sequence D
intervention type: Drug
intervention name: DWC202003
description: 300mg single dose
arm group label: Sequence A
arm group label: Sequence B
arm group label: Sequence C
intervention type: Drug
intervention name: DWC202004
description: 300mg single dose
arm group label: Sequence B
arm group label: Sequence C
arm group label: Sequence D
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bo-Hyung Kim
phone: +82-2-958-9326
email: bhkim98@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: No