<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/NCT03017950</url>
  </required_header>
  <id_info>
    <org_study_id>170DDI16017</org_study_id>
    <nct_id>NCT03017950</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Drug-drug Interaction of CKD-330 and D086</brief_title>
  <official_title>Phase I Clinical Trial to Evaluate the Pharmacokinetic Drug-drug Interaction of CKD-330 and D086 in Healthy Male Volunteers</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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is examining and comparing the pharmacokinetic drug interaction and&#xD;
      safety of both single administration and combination administration of CKD-330 and D086 to&#xD;
      healthy male subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label, randomized, multiple-dose, 2-sequence, 2-period, 2-treatment, crossover study&#xD;
&#xD;
      Part1: Examining how D086 affects pharmacokinetics of CKD-330. Part2: Examining how CKD-330&#xD;
      affects pharmacokinetics of D086.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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,ss of Candesartan and Amlodipine</measure>
    <time_frame>Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin</measure>
    <time_frame>Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Hypertension</condition>
  <condition>Hyperlipidemias</condition>
  <arm_group>
    <arm_group_label>Part1 (A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Number of Subjects: 10&#xD;
Number of days for Period 1: 8&#xD;
Number of days for Period 2: 8&#xD;
Number of days for wash-out between period 1 and period 2: 14&#xD;
IPs for Period 1: CKD-330&#xD;
IPs for Period 2: CKD-330 + D086</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part1 (B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Number of Subjects: 10&#xD;
Number of days for Period 1: 8&#xD;
Number of days for Period 2: 8&#xD;
Number of days for wash-out between period 1 and period 2: 14&#xD;
IPs for Period 1: CKD-330 + D086&#xD;
IPs for Period 2: CKD-330</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part2 (A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Number of Subjects: 30&#xD;
Number of days for Period 1: 8&#xD;
Number of days for Period 2: 8&#xD;
Number of days for wash-out between period 1 and period 2: 14&#xD;
IPs for Period 1: D086&#xD;
IPs for Period 2: CKD-330 + D086</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part2 (B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Number of Subjects: 30&#xD;
Number of days for Period 1: 8&#xD;
Number of days for Period 2: 8&#xD;
Number of days for wash-out between period 1 and period 2: 14&#xD;
IPs for Period 1: CKD-330 + D086&#xD;
IPs for Period 2: D086</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-330</intervention_name>
    <arm_group_label>Part1 (A)</arm_group_label>
    <arm_group_label>Part1 (B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D086</intervention_name>
    <arm_group_label>Part2 (A)</arm_group_label>
    <arm_group_label>Part2 (B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-330 + D086</intervention_name>
    <arm_group_label>Part1 (A)</arm_group_label>
    <arm_group_label>Part1 (B)</arm_group_label>
    <arm_group_label>Part2 (A)</arm_group_label>
    <arm_group_label>Part2 (B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult males age of between 19 - 45 on the day of screening.&#xD;
&#xD;
          2. Body mass index(BMI) between 18.0 - 29.0 kg/m^2 and weight ≥ 55kg (Body mass index&#xD;
             (BMI) = weight (kg) / height (m)^2)&#xD;
&#xD;
          3. Subjects in good health as determined by physical exams and medical examinations. No&#xD;
             congenital or chronic diseases and no abnormal signs determined by medical&#xD;
             examinations.&#xD;
&#xD;
          4. Not abnormal or not clinically significant lab values.&#xD;
&#xD;
          5. Subjects who signed informed consent form with good understandings after explanations&#xD;
             by investigators.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No history or presence of clinically significant cardiac, respiratory, neurological,&#xD;
             endocrine, metal and renal diseases and liver and kidney diseases.&#xD;
&#xD;
          2. Subjects showing angioedema as an adverse reaction to ACE inhibitors&#xD;
&#xD;
          3. Primary Hyperaldosteronism&#xD;
&#xD;
          4. History or family history of myopathy&#xD;
&#xD;
          5. Subjects with mental diseases or drug addiction&#xD;
&#xD;
          6. Allergic reactions to candesartan or amlodipine or atorvastatin&#xD;
&#xD;
          7. Genetic problems in galactose intolerance, Lapp lactose deficiency, or&#xD;
             glucose-galactose malabsorption.&#xD;
&#xD;
          8. Hypotension(SBP ≤100mmHg or DBP≤55mnHg) or hypertension ( SNP ≥ 150mmHg, DBP ≥95mmHg)&#xD;
             on the day of screening&#xD;
&#xD;
          9. Subjects who experienced gastrointestinal diseases or surgeries which can affect&#xD;
             absorption of Investigational product&#xD;
&#xD;
         10. Subjects with abnormal lab values at least one below&#xD;
&#xD;
             (AST or ALT&gt;2 fold of upper normal limit, Total bilirubin&gt;2 fold of upper normal&#xD;
             limit, CPK&gt;2 fold of upper normal limit, K &lt;3.5mEq/L or &gt;5.5mEq/L, Estimated&#xD;
             Glomerular filtration rate&lt;60mL/min/1.73m2 by Modification)&#xD;
&#xD;
         11. Continuous drinking (over 21 units/week, 1 unit= 10g=12.5mL of pure alcohol), heavy&#xD;
             smoker(&gt; 10 cigarettes per day) and unable to stop drinking during clinical trials&#xD;
&#xD;
         12. Subjects who previously participated in other clinical trials within 90 days&#xD;
&#xD;
         13. Subjects who donated whole blood within 60 days or donated component blood within 30&#xD;
             days or received blood transfusion within 30 days&#xD;
&#xD;
         14. Subjects who were administered below medications within 30 days (cyclosporin,&#xD;
             erythromycin, clarithromycin, lopinavir, ritonavir, itraconazole, ketoconazole,&#xD;
             rifampicin, barbiturate : theses medicines could affect absorption, metabolism,&#xD;
             distribution and excretion of candesartan,amlodipine and atorvastatin)&#xD;
&#xD;
         15. Subjects who took any prescribed medications or oriental medicines within 14 days, or&#xD;
             took any pharmacy medicines within 7 days.&#xD;
&#xD;
         16. Subjects who have taken any diets affecting absorption, metabolism, distribution and&#xD;
             excretion of investigational products (especially grapefruit juice).&#xD;
&#xD;
         17. Subjects who are in conditions impossible participating in the clinical trials&#xD;
             following other laboratory tests.&#xD;
&#xD;
         18. Unable to use contraceptions.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</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>Hyperlipidemias</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/NCT03017950
org study id: 170DDI16017
nct id: NCT03017950
lead sponsor: 
has dmc: No
The purpose of the study is examining and comparing the pharmacokinetic drug interaction and
      safety of both single administration and combination administration of CKD-330 and D086 to
      healthy male subjects
An open-label, randomized, multiple-dose, 2-sequence, 2-period, 2-treatment, crossover study

      Part1: Examining how D086 affects pharmacokinetics of CKD-330. Part2: Examining how CKD-330
      affects pharmacokinetics of D086.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCτ,ss of Candesartan and Amlodipine
time frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
measure: AUCτ,ss of atorvastatin and 2-hydroxy atorvastatin
time frame: Day6, Day7, Day8, Day9, Day22, Day27, Day28, Day29 and Day30
arm group label: Part1 (A)
arm group type: Experimental
description: Number of Subjects: 10
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330
IPs for Period 2: CKD-330 + D086
arm group label: Part1 (B)
arm group type: Experimental
description: Number of Subjects: 10
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330 + D086
IPs for Period 2: CKD-330
arm group label: Part2 (A)
arm group type: Experimental
description: Number of Subjects: 30
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: D086
IPs for Period 2: CKD-330 + D086
arm group label: Part2 (B)
arm group type: Experimental
description: Number of Subjects: 30
Number of days for Period 1: 8
Number of days for Period 2: 8
Number of days for wash-out between period 1 and period 2: 14
IPs for Period 1: CKD-330 + D086
IPs for Period 2: D086
intervention type: Drug
intervention name: CKD-330
arm group label: Part1 (A)
arm group label: Part1 (B)
intervention type: Drug
intervention name: D086
arm group label: Part2 (A)
arm group label: Part2 (B)
intervention type: Drug
intervention name: CKD-330 + D086
arm group label: Part1 (A)
arm group label: Part1 (B)
arm group label: Part2 (A)
arm group label: Part2 (B)
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hyperlipidemias
sharing ipd: No