<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/NCT03774355</url>
  </required_header>
  <id_info>
    <org_study_id>CG100649-1-07</org_study_id>
    <nct_id>NCT03774355</nct_id>
  </id_info>
  <brief_title>Study to Compare Safety and Pharmacokinetics of &quot;CG1801&quot; and &quot;CGL1802&quot; in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Open-label, Single, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of &quot;CG1801&quot; and &quot;CGL1802&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>
      The objective of this open-label, randomized, 2*2 crossover study is to compare the safety&#xD;
      and Pharmacokinetics CG1801 and CGL1802 in Healthy Volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy volunteers are administrated single-dose over the period I and II (crossover) of&#xD;
      CGL1802(Polmacoxib 2mg Tablet) and CG1801(Polmacoxib 2mg capsule) Every time before and after&#xD;
      each medication, pharmacokinetic (PK) parameters and safety of CGL1802 and CG1801 is&#xD;
      performed using a blood sample and conducting some tests (vital signs, physical exam, ECG,&#xD;
      laboratory test, etc.) respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">May 3, 2019</completion_date>
  <primary_completion_date type="Actual">May 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>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under Curve [AUC]last of polmacoxib AUClast of polmacoxib AUClast of polmacoxib AUClast of polmacoxib</measure>
    <time_frame>Day1 pre-dose and each of the post-doses of each of the 2 treatment periods in CG1801 and CGL1802 Group.</time_frame>
    <description>Area Under Curve [AUC]last of CGL1802 will be evaluated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Plasma Concentration [Cmax] of polmacoxib</measure>
    <time_frame>Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.</time_frame>
    <description>Maximum Plasma Concentration [Cmax] of CGL1802 will be evaluated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under Curve [AUC]last of polmacoxib</measure>
    <time_frame>Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration [Cmax] of polmacoxib</measure>
    <time_frame>Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCinf of polmacoxib</measure>
    <time_frame>Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration [Tmax] of polmacoxib</measure>
    <time_frame>Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 of polmacoxib</measure>
    <time_frame>Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clearance [CL/F] of Polmacoxib</measure>
    <time_frame>Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution [Vd/F] of Polmacoxib</measure>
    <time_frame>Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>CG1801</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosing 'CG1801' followed by dosing 'CGL1802'</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CGL 1802</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosing 'CGL1802' followed by dosing 'CG1801'</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CG1801</intervention_name>
    <description>Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2.</description>
    <arm_group_label>CG1801</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CGL1802</intervention_name>
    <description>Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2</description>
    <arm_group_label>CGL 1802</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        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. After taking a rest in sitting position for 5 minutes, subjects who have blood&#xD;
             pressure (90 mmHg ≤ Systolic BP ≤ 139 mmHg, and 60 mmHg ≤ Diastolic BP ≤ 89 mmHg)&#xD;
&#xD;
          6. 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;
          7. Negative pregnancy test(hCG) and agree to contraception during the trial&#xD;
&#xD;
        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. Uncontrolled hypertension (over the Systolic BP 140 mm Hg or Diastolic BP 90 mmHG)&#xD;
&#xD;
          5. Edema or Fluid retention&#xD;
&#xD;
          6. AST / ALT &gt; 1.5 times the normal range including additional and Screening blood tests&#xD;
             before randomization.&#xD;
&#xD;
          7. MDRD &lt; 60mL / min / 1.73m2 including additional and Screening blood tests before&#xD;
             randomization.&#xD;
&#xD;
          8. Patient with an active peptic ulcer or gastrointestinal bleeding&#xD;
&#xD;
          9. Patient with inflammatory intestinal disease such as Crohn's disease or ulcerative&#xD;
             colitis&#xD;
&#xD;
         10. Patient with Congestive Heart Failure (NYHA II - IV)&#xD;
&#xD;
         11. Established ischemic heart disease patients, peripheral arterial diseases, and/or&#xD;
             brain vascular diseases patient&#xD;
&#xD;
         12. Patient performed CABG within 30 days prior to the first administration of the&#xD;
             investigational drug&#xD;
&#xD;
         13. Patient has hyperkalemia&#xD;
&#xD;
         14. Patient has blood coagulation disorder or administration the anticoagulant&#xD;
&#xD;
         15. Patient with gastrointestinal related disease or gastrotomy history (except&#xD;
             appendicitis or hernia surgery) that may affect the absorption of the investigational&#xD;
             drug.&#xD;
&#xD;
         16. Patient participated in any other clinical trials or Bio-equivalence studies within 90&#xD;
             days prior to the screening visit.&#xD;
&#xD;
         17. Patient donated whole blood within 60 days, donated blood component within 14 days, or&#xD;
             received blood transfusion within 30 days prior to the first administration of the&#xD;
             investigational drug.&#xD;
&#xD;
         18. Taken medications like barbital or herbal medicines within 30 days or taken Over The&#xD;
             Counter medicines within 7 days prior to the first administration of the&#xD;
             investigational drug that may affect the clinical trial&#xD;
&#xD;
         19. Over smokers (tobacco &gt; 20 cigarettes/ days) within 30 days prior to Screening visit&#xD;
             or patient cannot quit smoking during and until the end of the clinical trial after&#xD;
             signed the Informed Consent Form to participate the clinical trial.&#xD;
&#xD;
         20. Excessive Alcohol consumer 30 days prior to Screening visit or cannot quit drinking&#xD;
             alcohol during and until the end of the clinical trial after signed the Informed&#xD;
             Consent Form to participate the clinical trial.&#xD;
&#xD;
         21. Excessive caffeine consumer (&gt; 5 drinks/ day)&#xD;
&#xD;
         22. Breast Feeding woman&#xD;
&#xD;
         23. Patient cannot accept medically acceptable contraception during and until the clinical&#xD;
             trial.&#xD;
&#xD;
         24. 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>September 2019</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 12, 2018</study_first_posted>
  <last_update_submitted>September 23, 2019</last_update_submitted>
  <last_update_submitted_qc>September 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</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/NCT03774355
org study id: CG100649-1-07
nct id: NCT03774355
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this open-label, randomized, 2*2 crossover study is to compare the safety
      and Pharmacokinetics CG1801 and CGL1802 in Healthy Volunteers.
Healthy volunteers are administrated single-dose over the period I and II (crossover) of
      CGL1802(Polmacoxib 2mg Tablet) and CG1801(Polmacoxib 2mg capsule) Every time before and after
      each medication, pharmacokinetic (PK) parameters and safety of CGL1802 and CG1801 is
      performed using a blood sample and conducting some tests (vital signs, physical exam, ECG,
      laboratory test, etc.) respectively.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under Curve [AUC]last of polmacoxib AUClast of polmacoxib AUClast of polmacoxib AUClast of polmacoxib
time frame: Day1 pre-dose and each of the post-doses of each of the 2 treatment periods in CG1801 and CGL1802 Group.
description: Area Under Curve [AUC]last of CGL1802 will be evaluated
measure: Maximum Plasma Concentration [Cmax] of polmacoxib
time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
description: Maximum Plasma Concentration [Cmax] of CGL1802 will be evaluated
measure: Area Under Curve [AUC]last of polmacoxib
time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
measure: Maximum Plasma Concentration [Cmax] of polmacoxib
time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
measure: AUCinf of polmacoxib
time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
measure: Time to maximum plasma concentration [Tmax] of polmacoxib
time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
measure: t1/2 of polmacoxib
time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
measure: clearance [CL/F] of Polmacoxib
time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
measure: Volume of distribution [Vd/F] of Polmacoxib
time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
arm group label: CG1801
arm group type: Experimental
description: Dosing 'CG1801' followed by dosing 'CGL1802'
arm group label: CGL 1802
arm group type: Experimental
description: Dosing 'CGL1802' followed by dosing 'CG1801'
intervention type: Drug
intervention name: CG1801
description: Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2.
arm group label: CG1801
intervention type: Drug
intervention name: CGL1802
description: Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2
arm group label: CGL 1802
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