<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/NCT04418388</url>
  </required_header>
  <id_info>
    <org_study_id>PBK_1801_101</org_study_id>
    <nct_id>NCT04418388</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women</brief_title>
  <official_title>A Single Center, Open-label Clinical Trial to Evaluate Pharmacokinetic Characteristics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharmbio Korea Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pharmbio Korea Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess the pharmacokinetic characteristics after a&#xD;
      single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for&#xD;
      Koreans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2019</start_date>
  <completion_date type="Actual">December 23, 2019</completion_date>
  <primary_completion_date type="Actual">December 3, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCinf</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vd/F</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBK-1801</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBK-1801</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBK-1801</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) between 19 and 30 kg/m²&#xD;
&#xD;
          -  Subjects are to be in good general health according to medical history, physical&#xD;
             examination, electrocardiograph (ECG) recording and clinical laboratory assessments&#xD;
             showing no signs clinically significant pathology (A subject with a clinically&#xD;
             insignificant abnormality may be included by the discretion of the investigator)&#xD;
&#xD;
          -  Subjects are to have given their written informed consent to participate in the study&#xD;
             and to abide by study restrictions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or evidence of clinically significant cardiovascular, renal, hepatic,&#xD;
             hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological,&#xD;
             psychiatric or other major disease&#xD;
&#xD;
          -  Subjects who have any condition possibly affecting drug absorption (e.g., previous&#xD;
             surgery on the gastrointestinal tract other than uncomplicated appendectomy,&#xD;
             inflammatory bowel disease).&#xD;
&#xD;
          -  History or current alcohol abuse or drug addiction&#xD;
&#xD;
          -  Subjects who for any reason, are deemed by the Investigator to be inappropriate for&#xD;
             this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>SeungHwan Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</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/NCT04418388
org study id: PBK_1801_101
nct id: NCT04418388
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The primary objective of this study is to assess the pharmacokinetic characteristics after a
      single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for
      Koreans.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax
time frame: 5 days
measure: AUClast
time frame: 5 days
measure: AUCinf
time frame: 5 days
measure: Tmax
time frame: 5 days
measure: T1/2
time frame: 5 days
measure: CL/F
time frame: 5 days
measure: Vd/F
time frame: 5 days
measure: Number of Participants with Adverse Events
time frame: 30 days
arm group label: A
arm group type: Experimental
arm group label: B
arm group type: Experimental
arm group label: C
arm group type: Experimental
intervention type: Drug
intervention name: PBK-1801
description: Administered orally
arm group label: A
intervention type: Drug
intervention name: PBK-1801
description: Administered orally
arm group label: B
intervention type: Drug
intervention name: PBK-1801
description: Administered orally
arm group label: C
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: SeungHwan Lee
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor