<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/NCT03775629</url>
  </required_header>
  <id_info>
    <org_study_id>CG100650-1-01</org_study_id>
    <nct_id>NCT03775629</nct_id>
  </id_info>
  <brief_title>Drug-Drug Interaction Study of &quot;CG100650&quot; in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of &quot;CG100650&quot; in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CrystalGenomics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CrystalGenomics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized, open-label, multiple-dose, parallel, Phase 1 study to compare the&#xD;
      pharmacokinetics and to evaluate Drug-Drug Interaction of &quot;CG100650&quot; in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, open label, multiple-dose, parallel study to compare PK and to evaluate&#xD;
      Drug-Drug Interaction of CG100650 in healthy volunteers.&#xD;
&#xD;
      Total of 39 health volunteers will be randomized to receive either of Group A, B or C for 14&#xD;
      days (13 subjects each).&#xD;
&#xD;
      [Group A] Tramadol +Polmacoxib capsule [Group B] Polmacoxib capsule [Group C] Tramadol&#xD;
&#xD;
      Pharmacokinetic parameters will be evaluated as primary endpoint by changes from baseline;&#xD;
&#xD;
      Safety evaluation will be carried out by conducting vital sign, laboratory test, ECG, and&#xD;
      collecting AE, CM by different Group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">April 10, 2019</completion_date>
  <primary_completion_date type="Actual">April 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Group A: Tramadol hydrochloride +Polmacoxib Group B: Polmacoxib Group C: Tramadol hydrochloride</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUCtau of Polmacoxib and Tramadol</measure>
    <time_frame>up to 4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Polmacoxib and Tramadol</measure>
    <time_frame>up to 4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax of Polmacoxib</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC tau of Polmacoxib</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of Tramadol</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCtau of Tramadol</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Polmacoxib and Tramadol combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tramadol + Polmacoxib capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polmacoxib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Polmacoxib</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tramadol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tramadol hydrochloride (HCl)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polmacoxib and Tramadol combination</intervention_name>
    <description>Tramadol hydrochloride , Polmacoxib</description>
    <arm_group_label>Polmacoxib and Tramadol combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polmacoxib</intervention_name>
    <description>Polmacoxib</description>
    <arm_group_label>Polmacoxib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tramadol hydrochloride</intervention_name>
    <description>Tramadol hydrochloride (HCl)</description>
    <arm_group_label>Tramadol</arm_group_label>
    <other_name>Tramadol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Male or female aged ≥ 19 years and ≤ 50 years&#xD;
&#xD;
          2. Without inborn or chronic disease and no symptoms in physical examination&#xD;
&#xD;
          3. BMI(Body Mass Index) result ≥ 18kg/m 2 and ≤ 30kg/m2&#xD;
&#xD;
          4. Adequate clinical laboratory test results as evidenced by Hematology, Hemostasis,&#xD;
             Biochemistry, Urinalysis, Serology and so on&#xD;
&#xD;
          5. Subject who understand the objective, method of the study and the characteristics of&#xD;
             investigational drug and expected adverse events and provide written informed consent&#xD;
             prior to study participation&#xD;
&#xD;
          6. Negative pregnancy test(hCG) and agree to contraception during the trial&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. History of hypersensitivity to investigational products&#xD;
&#xD;
          2. History of hypersensitivity or allergic reaction to sulfonamide.&#xD;
&#xD;
          3. Patients with a history of asthma, acute rhinitis, nonspecific polyps, angioedema,&#xD;
             urticaria or allergic reactions to aspirin or other nonsteroidal anti- inflammatory&#xD;
             analgesics (including COX-2 inhibitors)&#xD;
&#xD;
          4. Genetically galactose intolerance, lactose intolerance or Glucose-Galactose&#xD;
             Malabsorption&#xD;
&#xD;
          5. Any other reasons or situations that the investigator decides the patient is not&#xD;
             eligible to participate the clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyung-Sang Yu, Ph.D.</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>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tramadol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03775629
org study id: CG100650-1-01
nct id: NCT03775629
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized, open-label, multiple-dose, parallel, Phase 1 study to compare the
      pharmacokinetics and to evaluate Drug-Drug Interaction of "CG100650" in healthy volunteers.
This is a randomized, open label, multiple-dose, parallel study to compare PK and to evaluate
      Drug-Drug Interaction of CG100650 in healthy volunteers.

      Total of 39 health volunteers will be randomized to receive either of Group A, B or C for 14
      days (13 subjects each).

      [Group A] Tramadol +Polmacoxib capsule [Group B] Polmacoxib capsule [Group C] Tramadol

      Pharmacokinetic parameters will be evaluated as primary endpoint by changes from baseline;

      Safety evaluation will be carried out by conducting vital sign, laboratory test, ECG, and
      collecting AE, CM by different Group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group A: Tramadol hydrochloride +Polmacoxib Group B: Polmacoxib Group C: Tramadol hydrochloride
primary purpose: Treatment
masking: None (Open Label)
measure: AUCtau of Polmacoxib and Tramadol
time frame: up to 4 weeks
measure: Cmax of Polmacoxib and Tramadol
time frame: up to 4 weeks
measure: Cmax of Polmacoxib
time frame: up to 4 weeks
measure: AUC tau of Polmacoxib
time frame: up to 4 weeks
measure: Cmax of Tramadol
time frame: up to 4 weeks
measure: AUCtau of Tramadol
time frame: up to 4 weeks
arm group label: Polmacoxib and Tramadol combination
arm group type: Experimental
description: Tramadol + Polmacoxib capsule
arm group label: Polmacoxib
arm group type: Active Comparator
description: Polmacoxib
arm group label: Tramadol
arm group type: Active Comparator
description: Tramadol hydrochloride (HCl)
intervention type: Drug
intervention name: Polmacoxib and Tramadol combination
description: Tramadol hydrochloride , Polmacoxib
arm group label: Polmacoxib and Tramadol combination
intervention type: Drug
intervention name: Polmacoxib
description: Polmacoxib
arm group label: Polmacoxib
intervention type: Drug
intervention name: Tramadol hydrochloride
description: Tramadol hydrochloride (HCl)
arm group label: Tramadol
other name: Tramadol
criteria: 
gender: All
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kyung-Sang Yu, Ph.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Tramadol