xml: <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/NCT06008028</url>
    </required_header>
    <id_info>
      <org_study_id>BR-FIC-CT-101</org_study_id>
      <nct_id>NCT06008028</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Pharmacokinetics and the Safety After Administration of &quot;BR1015&quot; and Co-administration of &quot;BR1015-1&quot; and &quot;BR1015-2&quot; Under Fasting Conditions in Healthy Volunteers</brief_title>
    <official_title>An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 4-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of &quot;BR1015&quot; and Co-administration of &quot;BR1015-1&quot; and &quot;BR1015-2&quot; in Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boryung Pharmaceutical Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boryung 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 clinical trial is to evaluate the pharmacokinetics and the safety after&#xD;
        administration of &quot;BR1015&quot; and co-administration of &quot;BR1015-1&quot; and &quot;BR1015-2&quot; under fasting&#xD;
        conditions in healthy volunteers&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>AUCτ</measure>
      <time_frame>0-72 hours after administration</time_frame>
      <description>Area under the concentration-time curve from time zero to time τ</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax</measure>
      <time_frame>0-72 hours after administration</time_frame>
      <description>Maximum concentration of drug in plasma</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">57</enrollment>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>BR1015</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BR1015-1 + BR1015-2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BR1015</intervention_name>
      <description>One tablet administered alone</description>
      <arm_group_label>BR1015</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BR1015-1</intervention_name>
      <description>One tablet administered alone</description>
      <arm_group_label>BR1015-1 + BR1015-2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BR1015-2</intervention_name>
      <description>One tablet administered alone</description>
      <arm_group_label>BR1015-1 + BR1015-2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0&#xD;
               to 30.0kg/m2 at screening visit.&#xD;
  &#xD;
            -  Those who sign written consent spontaneously after listening to and understanding&#xD;
               sufficient explanation of the purpose and contents of this clinical trial,&#xD;
               characteristics of the Investigational products, expected adverse events, etc.&#xD;
  &#xD;
            -  Those who agree to rule out the possibility of their and their spouses' or sexual&#xD;
               partners' pregnancy by using methods of contraception accepted in clinical trial* from&#xD;
               the date of the first administration of the investigational products to 14 days after&#xD;
               the last administration and disagrees to provide their sperm or ovum.&#xD;
  &#xD;
                 -  Methods of contraception accepted in clinical trial: Combined use of intrauterine&#xD;
                    device, vasectomy, tubal ligation, and barrier methods (male condom, female&#xD;
                    condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more&#xD;
                    barrier methods if spermicide is used.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who have taken drugs that induce and inhibit metabolizing enzymes such as&#xD;
               barbiturate within 30 days prior to the first day of administration or have taken&#xD;
               drugs concerned about affecting this clinical trial within 10 days prior to the first&#xD;
               day of administration. (however, participation is possible considering&#xD;
               pharmacokinetics and pharmacodynamics such as Interaction of investigational products,&#xD;
               half-life of concomitant drugs)&#xD;
  &#xD;
            -  Those who have participated in other clinical trials(including bioequivalence tests)&#xD;
               and administered their investigational products within 6 months prior to the first&#xD;
               administration date.(However, the termination for participation in other clinical&#xD;
               trials are based on the last administration date of their investigational products)&#xD;
  &#xD;
            -  Those who have a medical history of gastrointestinal surgery or gastrointestinal&#xD;
               diseases that may affect the absorption of drugs. (Except for simple appendectomy,&#xD;
               hernia surgery)&#xD;
  &#xD;
            -  In the case of a female subject, those suspected pregnancy, pregnant woman, lactating&#xD;
               woman.&#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>
    <location>
      <facility>
        <name>Clinical Research Center, H PLUS Yangji Hospital</name>
        <address>
          <city>Seoul</city>
          <state>Gwanakgu</state>
          <zip>08779</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008028
  org study id: BR-FIC-CT-101
  nct id: NCT06008028
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after
        administration of "BR1015" and co-administration of "BR1015-1" and "BR1015-2" under fasting
        conditions in healthy volunteers
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: AUCτ
  time frame: 0-72 hours after administration
  description: Area under the concentration-time curve from time zero to time τ
  measure: Cmax
  time frame: 0-72 hours after administration
  description: Maximum concentration of drug in plasma
  arm group label: BR1015
  arm group type: Experimental
  arm group label: BR1015-1 + BR1015-2
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: BR1015
  description: One tablet administered alone
  arm group label: BR1015
  intervention type: Drug
  intervention name: BR1015-1
  description: One tablet administered alone
  arm group label: BR1015-1 + BR1015-2
  intervention type: Drug
  intervention name: BR1015-2
  description: One tablet administered alone
  arm group label: BR1015-1 + BR1015-2
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Hypertension
  sharing ipd: No