<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/NCT02186496</url>
  </required_header>
  <id_info>
    <org_study_id>144BE14002</org_study_id>
    <nct_id>NCT02186496</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study (Candesartan 8 mg and Amlodipine 5 mg)</brief_title>
  <official_title>A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330 (Fixed-dose Combination of Candesartan 8 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs 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 this study is to compare the safety and pharmacokinetics of CKD-330&#xD;
      (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the&#xD;
      two separate drugs in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</time_frame>
    <description>A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr&#xD;
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</time_frame>
    <description>A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr&#xD;
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCinf</measure>
    <time_frame>0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</time_frame>
    <description>A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr&#xD;
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax</measure>
    <time_frame>0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</time_frame>
    <description>A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr&#xD;
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2β</measure>
    <time_frame>0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</time_frame>
    <description>A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr&#xD;
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F</measure>
    <time_frame>0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</time_frame>
    <description>A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr&#xD;
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Candesartan and Amlodipine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Candesartan 8mg and Amlodipine 5mg, PO, 1days or 22days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CKD-330</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CKD-330 8/5mg, PO, 1days or 22days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-330 8/5mg</intervention_name>
    <arm_group_label>CKD-330</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Candesartan 8mg and Amlodipine 5mg</intervention_name>
    <arm_group_label>Candesartan and Amlodipine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male volunteer in the age between 20 and 45 years old.&#xD;
&#xD;
          2. Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.&#xD;
&#xD;
          3. Subjects without a hereditary problems and chronic disease.&#xD;
&#xD;
          4. Subjects whose clinical laboratory test values are inside the accepted normal range.&#xD;
&#xD;
          5. Understand the requirements of the study and voluntarily consent to participate in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous history or present of clinically significant hepatobiliary, nephrological,&#xD;
             neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric,&#xD;
             musculoskeletal, immune, otorhinolaryngological, cardiovascular system.&#xD;
&#xD;
          2. History of gastrointestinal disease or gastrointestinal surgery to affect drug&#xD;
             absorption.&#xD;
&#xD;
          3. History of clinically significant allergies of amlodipine or candesartan or CCB or ARB&#xD;
             or aspirin or antibiotic.&#xD;
&#xD;
          4. Subjects with galactose intolerance.&#xD;
&#xD;
          5. SBP ≥ 140 mmHg or&lt; 90 mmHg, DBP ≥ 95 mmHg or &lt; 60 mmHg, pulse ≥ 100 BPM.&#xD;
&#xD;
          6. AST or ALT &gt; 2*ULN, total bilirubin &gt; 2*ULN&#xD;
&#xD;
          7. Serum Creatinine &gt; ULN&#xD;
&#xD;
          8. Previous history or present of drug abuse.&#xD;
&#xD;
          9. Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1&#xD;
             month prior to the first dosing.&#xD;
&#xD;
         10. Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within&#xD;
             1 week prior to the first dosing.&#xD;
&#xD;
         11. Subjects treated IP within 2 months prior to the first dosing.&#xD;
&#xD;
         12. Subjects with whole blood donation within 2 months or component blood donation within&#xD;
             1 month or blood transfusion within 1 month prior to the first dosing.&#xD;
&#xD;
         13. Alcohol &gt; 21 units/week or cannot stop drinking.&#xD;
&#xD;
         14. Cigarette &gt; 10 cigarettes/day.&#xD;
&#xD;
         15. Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or&#xD;
             any surgery(plastic surgery, eye surgery - LASIK, LASEK).&#xD;
&#xD;
         16. Not eligible to participate for the study at the discretion of investigator.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jang Hee Hong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chungnam National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <state>Chungcheongbuk-do</state>
        <zip>301-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>November 27, 2014</last_update_submitted>
  <last_update_submitted_qc>November 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</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>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Candesartan</mesh_term>
    <mesh_term>Candesartan cilexetil</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/NCT02186496
org study id: 144BE14002
nct id: NCT02186496
lead sponsor: 
has dmc: No
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330
      (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the
      two separate drugs in healthy male volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCt
time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
description: A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
measure: Cmax
time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
description: A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
measure: AUCinf
time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
description: A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
measure: tmax
time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
description: A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
measure: t1/2β
time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
description: A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
measure: CL/F
time frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
description: A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
arm group label: Candesartan and Amlodipine
arm group type: Experimental
description: Candesartan 8mg and Amlodipine 5mg, PO, 1days or 22days
arm group label: CKD-330
arm group type: Experimental
description: CKD-330 8/5mg, PO, 1days or 22days
intervention type: Drug
intervention name: CKD-330 8/5mg
arm group label: CKD-330
intervention type: Drug
intervention name: Candesartan 8mg and Amlodipine 5mg
arm group label: Candesartan and Amlodipine
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jang Hee Hong
role: Principal Investigator
affiliation: Chungnam National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Amlodipine
mesh term: Candesartan
mesh term: Candesartan cilexetil