<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/NCT04478097</url>
  </required_header>
  <id_info>
    <org_study_id>A70_09BE2005</org_study_id>
    <nct_id>NCT04478097</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Open, Single-dose, 3 Period Partial Replicated Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-333 or Co-administration of CKD-330 and D086 in Healthy Volunteers Under Fasting Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</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 study is a randomized, open, single-dose, 3 period partial replicated crossover-design&#xD;
      study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy&#xD;
      volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To healthy subjects of fifty-one (51), following treatments are administered dosing in each&#xD;
      period and wash-out period is a minimum of 14 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 14, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 5, 2020</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 of CKD-330, D086, CKD-333</measure>
    <time_frame>[Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]</time_frame>
    <description>Area under the CKD-330/D086/CKD-333 concentration in blood-time curve from zero to final</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of CKD-330, D086, CKD-333</measure>
    <time_frame>[Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]</time_frame>
    <description>The maximum CKD-330/D086/CKD-333 concentration in blood sampling time t</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">51</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Reference-Reference-Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference-Test-Reference</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Test-Reference-Reference</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-330 Tab. and D086 Tab.</intervention_name>
    <description>1T</description>
    <arm_group_label>Reference-Reference-Test</arm_group_label>
    <arm_group_label>Reference-Test-Reference</arm_group_label>
    <arm_group_label>Test-Reference-Reference</arm_group_label>
    <other_name>Reference</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-333 Tab.</intervention_name>
    <description>1T</description>
    <arm_group_label>Reference-Reference-Test</arm_group_label>
    <arm_group_label>Reference-Test-Reference</arm_group_label>
    <arm_group_label>Test-Reference-Reference</arm_group_label>
    <other_name>Test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adults over the age of 19 years and under the age of 55 years at the time of&#xD;
             screening&#xD;
&#xD;
          2. Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) &lt; 30.5kg/m2 and men's total body&#xD;
             weight ≥ 55 kg, women's total body weight ≥ 45 kg&#xD;
&#xD;
             * BMI = Weight(kg)/ Height(m)2&#xD;
&#xD;
          3. Individuals without congenital/chronic diseases and without abnormal symptoms or&#xD;
             diagnosis based on a medical examination within the last 3 years&#xD;
&#xD;
          4. Individuals who were deemed to be appropriate as study subjects following laboratory&#xD;
             tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital&#xD;
             signs, ECG etc. performed at screening&#xD;
&#xD;
          5. Individuals who signed an informed consent form and decided to participate in the&#xD;
             study after being fully informed of the study prior to participation&#xD;
&#xD;
          6. Individuals who agreed proper contraception during the study and did consent to not&#xD;
             donation of sperm 1 month after the last dose of study drug infusion&#xD;
&#xD;
          7. Individuals with the ability and willingness to participate the entire study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals with a medical evidence or a history of clinically significant&#xD;
             hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology,&#xD;
             urinary, cardiovascular, musculoskeletal or psychiatric&#xD;
&#xD;
          2. Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease&#xD;
             and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may&#xD;
             affect drug absorption&#xD;
&#xD;
          3. Individuals with the following results at screening test:&#xD;
&#xD;
               -  ALT or AST &gt; 2x the upper limit of the normal range&#xD;
&#xD;
               -  Creatinine &gt; upper limit of the normal range or eGFR with MDRD &lt;60 ml/min/1.73 m2&#xD;
&#xD;
               -  ECG Result, QTc &gt; 450msec&#xD;
&#xD;
               -  CPK &gt; UNL(upper normal limit) x 3.0&#xD;
&#xD;
               -  K &gt; 5.5mEq/l&#xD;
&#xD;
               -  Hct &lt; lower limit of the normal range&#xD;
&#xD;
          4. A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1&#xD;
             unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from&#xD;
             48hr prior to the first dose to end of last blooding (1 drink (250 mL) of beer (5%) =&#xD;
             10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12&#xD;
             g)&#xD;
&#xD;
          5. Individuals who smoked more than 20 cigarettes per day within 6 months prior to&#xD;
             screening or cannot quit smoking during hospitalization period&#xD;
&#xD;
          6. Individuals who had been administered investigational product(s) of other clinical&#xD;
             study or bioequivalence study within the 6 months prior to the first dose of this&#xD;
             study&#xD;
&#xD;
          7. Following vital signs results at screening&#xD;
&#xD;
               -  Sitting systolic blood pressure ≥ 140 mmHg or &lt; 90 mmHg&#xD;
&#xD;
               -  sitting diastolic blood pressure ≥90 mmHg or &lt;60 mmHg&#xD;
&#xD;
          8. Individuals with a medical history of significant drug abuse within one year prior to&#xD;
             the screening or positive for abuse drug in urine test results at screening&#xD;
&#xD;
          9. Individuals taking medication known to significantly induce or inhibit drug&#xD;
             metabolizing enzymes within 30days before the first administration of clinical trial&#xD;
             drug&#xD;
&#xD;
         10. Individuals who had taken prescription or nonprescription drugs within the 10 days&#xD;
             prior to the first dose of investigational product(s)&#xD;
&#xD;
         11. Individuals who donated whole blood within the 2 months, or blood components within 1&#xD;
             month prior to the first dose of the investigational product(s)&#xD;
&#xD;
         12. Individuals with hypersensitivity to investigational products or the investigational&#xD;
             products ingredients&#xD;
&#xD;
         13. Patients or conditions deemed to be at risk for using investigational products&#xD;
&#xD;
               -  Patient with hyperkalemia&#xD;
&#xD;
               -  Patients with hepatopathy&#xD;
&#xD;
               -  Patients with hereditary angioedema, ACE inhibitors or angiotensin 2 receptor&#xD;
                  antagonists who have a history of angioedema&#xD;
&#xD;
               -  Primary hyperaldosteronism&#xD;
&#xD;
               -  Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic&#xD;
                  obstructive cardiomyopathy&#xD;
&#xD;
               -  Patients with ischemic heart disease, ischemic cardiovascular disease,&#xD;
                  cerebrovascular disease&#xD;
&#xD;
               -  Patients with Intravascular volume depletion&#xD;
&#xD;
               -  Patients with diabetes or kidney failure&#xD;
&#xD;
               -  Patients with renal artery stenosis&#xD;
&#xD;
               -  Patients with muscle disease&#xD;
&#xD;
               -  Patients with Hypothyroidism&#xD;
&#xD;
               -  Patients with a history of muscle toxicity when using statins or fibrates&#xD;
&#xD;
               -  Patients who have recently had a kidney transplant&#xD;
&#xD;
               -  Patients with history of shock&#xD;
&#xD;
         14. Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency&#xD;
             or glucose-galactose malabsorption etc.&#xD;
&#xD;
         15. Individuals who drunk grapefruit juice or caffeine more than 5 cup per day within 3&#xD;
             months prior to screening or cannot quit drinking during clinical trials period&#xD;
&#xD;
         16. Individuals who cannot eat standard meal in institution&#xD;
&#xD;
         17. Women who are pregnant or may be pregnant&#xD;
&#xD;
         18. Individuals who were deemed to be inappropriate to participate in the study by the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jang Hee Hong</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</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>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04478097
org study id: A70_09BE2005
nct id: NCT04478097
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a randomized, open, single-dose, 3 period partial replicated crossover-design
      study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy
      volunteers.
To healthy subjects of fifty-one (51), following treatments are administered dosing in each
      period and wash-out period is a minimum of 14 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCt of CKD-330, D086, CKD-333
time frame: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
description: Area under the CKD-330/D086/CKD-333 concentration in blood-time curve from zero to final
measure: Cmax of CKD-330, D086, CKD-333
time frame: [Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
description: The maximum CKD-330/D086/CKD-333 concentration in blood sampling time t
arm group label: Reference-Reference-Test
arm group type: Experimental
arm group label: Reference-Test-Reference
arm group type: Experimental
arm group label: Test-Reference-Reference
arm group type: Experimental
intervention type: Drug
intervention name: CKD-330 Tab. and D086 Tab.
description: 1T
arm group label: Reference-Reference-Test
arm group label: Reference-Test-Reference
arm group label: Test-Reference-Reference
other name: Reference
intervention type: Drug
intervention name: CKD-333 Tab.
description: 1T
arm group label: Reference-Reference-Test
arm group label: Reference-Test-Reference
arm group label: Test-Reference-Reference
other name: Test
criteria: 
gender: All
minimum age: 19 Years
maximum age: 54 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No