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/NCT05993806</url>
    </required_header>
    <id_info>
      <org_study_id>CT-L04-103</org_study_id>
      <nct_id>NCT05993806</nct_id>
    </id_info>
    <brief_title>A Bioequivalence Study of L04TD3 Compared to Administration of L04RD1 in Healthy Volunteers</brief_title>
    <official_title>A Randomized, Open-label, Single-dose, Two-sequence, Two-period, Cross-over Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of L04TD3 and L04RD1 in Healthy Adult Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Celltrion</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Celltrion</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to&#xD;
        evaluate bioequivalence after administration of L04RD1 or administration of L04TD3 in healthy&#xD;
        volunteers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 2, 2023</start_date>
    <completion_date type="Actual">June 29, 2023</completion_date>
    <primary_completion_date type="Actual">June 12, 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>AUCt</measure>
      <time_frame>Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax</measure>
      <time_frame>Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>AUCinf (Area under the plasma concentration-time curve from time 0 to infinity)</measure>
      <time_frame>Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax (Time of peak plasma concentration)</measure>
      <time_frame>Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUCt/AUCinf</measure>
      <time_frame>Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>t1/2 (Half-life)</measure>
      <time_frame>Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CL/F</measure>
      <time_frame>Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Essential Hypertension</condition>
    <arm_group>
      <arm_group_label>A (L04RD1 -&gt; L04TD3)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD3</description>
    </arm_group>
    <arm_group>
      <arm_group_label>B (L04TD3 -&gt; L04RD1)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administration of 1 tablet of L04TD3, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>L04RD1</intervention_name>
      <description>1 tablet of L04RD1</description>
      <arm_group_label>A (L04RD1 -&gt; L04TD3)</arm_group_label>
      <arm_group_label>B (L04TD3 -&gt; L04RD1)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>L04TD3</intervention_name>
      <description>1 tablet of L04TD3</description>
      <arm_group_label>A (L04RD1 -&gt; L04TD3)</arm_group_label>
      <arm_group_label>B (L04TD3 -&gt; L04RD1)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A subject aged 19 to less than 65 years at the time of the screening visit&#xD;
  &#xD;
            -  A subject with a body weight of 55kg or higher and a body mass index (BMI) of 18.0&#xD;
               kg/m2 to 29.9 kg/m2, inclusive&#xD;
  &#xD;
            -  A subject considered appropriate to participate in the study according to the results&#xD;
               of lab tests such as the hematological test, blood chemistry test, serum test,&#xD;
               urinalysis, etc. and ECG set and conducted by the principal investigator (or a&#xD;
               delegated study physician) according to the characteristics of the investigational&#xD;
               product&#xD;
  &#xD;
            -  A subject who agreed to exclude the possibility of pregnancy by having themselves,&#xD;
               their spouses, or partners use medically appropriate contraceptive methods and not to&#xD;
               provide sperm or egg from the first dose to 7 days after the last dose of IP&#xD;
               administration&#xD;
  &#xD;
            -  A subject who voluntarily signed the informed consent form after listening to and&#xD;
               understanding sufficient explanation on the purpose, content of this clinical study,&#xD;
               the characteristics of the investigational product, expected adverse events, etc.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A subject who has clinically significant diseases in the digestive system,&#xD;
               cardiovascular system, endocrine system, respiratory system, blood and tumor,&#xD;
               infectious disease, kidney and genitourinary system, mental and nervous system,&#xD;
               musculoskeletal system, immune system, otolaryngeal system, skin system, and&#xD;
               ophthalmic system or has had the diseases&#xD;
  &#xD;
            -  A subject who had gastrointestinal surgery (excluding simple appendectomy or hernia&#xD;
               surgery) which may affect the absorption of drugs or have gastrointestinal diseases&#xD;
  &#xD;
            -  A subject who took drugs that induce and inhibit drug metabolizing enzymes such as&#xD;
               barbiturates within one month from the first administration date or drugs that might&#xD;
               affect this clinical study within 10 days from the first administration date (subjects&#xD;
               may participate depending on the pharmacodynamics and pharmacokinetics such as the&#xD;
               interactions with the investigational product, half-life, etc.)&#xD;
  &#xD;
            -  A subject who participated in another clinical study or bioequivalence study where&#xD;
               they were administered the investigational product within 6 months prior to the first&#xD;
               dose of the investigational drug&#xD;
  &#xD;
            -  A subject considered by the principal investigator (or a delegated study physician) as&#xD;
               inappropriate to participate in this clinical study due to reasons other than the&#xD;
               above inclusion and exclusion criteria&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>H plus Yangji Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>08756</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 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 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>Essential Hypertension</mesh_term>
    </condition_browse>
    <!-- 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/NCT05993806
  org study id: CT-L04-103
  nct id: NCT05993806
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to
        evaluate bioequivalence after administration of L04RD1 or administration of L04TD3 in healthy
        volunteers.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: AUCt
  time frame: Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
  measure: Cmax
  time frame: Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
  measure: AUCinf (Area under the plasma concentration-time curve from time 0 to infinity)
  time frame: Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
  measure: Tmax (Time of peak plasma concentration)
  time frame: Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
  measure: AUCt/AUCinf
  time frame: Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
  measure: t1/2 (Half-life)
  time frame: Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
  measure: CL/F
  time frame: Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
  arm group label: A (L04RD1 -> L04TD3)
  arm group type: Experimental
  description: Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD3
  arm group label: B (L04TD3 -> L04RD1)
  arm group type: Experimental
  description: Administration of 1 tablet of L04TD3, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1
  intervention type: Drug
  intervention name: L04RD1
  description: 1 tablet of L04RD1
  arm group label: A (L04RD1 -> L04TD3)
  arm group label: B (L04TD3 -> L04RD1)
  intervention type: Drug
  intervention name: L04TD3
  description: 1 tablet of L04TD3
  arm group label: A (L04RD1 -> L04TD3)
  arm group label: B (L04TD3 -> L04RD1)
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Essential Hypertension