<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/NCT02250833</url>
  </required_header>
  <id_info>
    <org_study_id>130HPS14006</org_study_id>
    <nct_id>NCT02250833</nct_id>
  </id_info>
  <brief_title>CKD-828 (80/5mg) Pharmacokinetic Study</brief_title>
  <official_title>To Compare the Pharmacokinetics and Safety of CKD-828 80/5mg to Coadministration of Telmisartan 80mg and S-amlodipine 5mg 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>
      A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the&#xD;
      pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration&#xD;
      telmisartan and s-amlodipine in health volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.</measure>
    <time_frame>up to 168 hours post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.</measure>
    <time_frame>up to 168 hours post dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.</measure>
    <time_frame>up to 168 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.</measure>
    <time_frame>up to 168 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.</measure>
    <time_frame>up to 168 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>up to 31days post dose</time_frame>
    <description>Adverse Event monitoring&#xD;
Evaluated safety parameters included: Physical examination, Vital sign, ECG, laboratory test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>CKD-828(Fixed Dose Combination)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Coadministration of Telmisartan 80mg and S-amlodipine 5mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-828</intervention_name>
    <description>Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily</description>
    <arm_group_label>CKD-828(Fixed Dose Combination)</arm_group_label>
    <other_name>Telminuvo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <description>- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine)</description>
    <arm_group_label>Combination Therapy</arm_group_label>
    <other_name>Micardis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-amlodipine</intervention_name>
    <description>- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)</description>
    <arm_group_label>Combination Therapy</arm_group_label>
    <other_name>Anydipine s</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A healthy volunteer between 20 and 55 years old&#xD;
&#xD;
          -  More than 50kg and within 20% of ideal body weight&#xD;
&#xD;
          -  No any congenital or chronic diseases and medical symptom&#xD;
&#xD;
          -  Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks&#xD;
             prior to the first IP administration&#xD;
&#xD;
          -  Signed the informed consent form prior to the study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of relevant hypersensitivity against drug&#xD;
&#xD;
          -  Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo,&#xD;
             hemato, onco, CNS etc.)&#xD;
&#xD;
          -  Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin &gt;&#xD;
             1.5*ULN)&#xD;
&#xD;
          -  SBP &lt;90mmHg or SBP &gt;150mmHg&#xD;
&#xD;
          -  DBP &lt;50mmHg or DBP &gt;100mmHg&#xD;
&#xD;
          -  Creatinine clearance &lt;80mL/min&#xD;
&#xD;
          -  A Disease(ex.inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic&#xD;
             disease history , gastro-intestinal surgery except for appendectomy)that may influence&#xD;
             on the absorption, distribution, metabolism and excretion of the drug&#xD;
&#xD;
          -  The evidence of severe attack or acute disease or surgical intervention within 28 days&#xD;
             prior to the first IP administration.&#xD;
&#xD;
          -  A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular&#xD;
             alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes&#xD;
             per a day)&#xD;
&#xD;
          -  Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within&#xD;
             7days prior to the first IP administration&#xD;
&#xD;
          -  Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP&#xD;
             administration) that may influence on the absorption, distribution, metabolism and&#xD;
             excretion of the drug&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-Ran Yoon</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyungpook National University Hospital Clinical Trial Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu, samdeok-dong, 2-ga 50</city>
        <state>samdeok-dong, 2-ga 50 Jung-gu</state>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>April 8, 2015</last_update_submitted>
  <last_update_submitted_qc>April 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>CKD-828</keyword>
  <keyword>Telmisartan</keyword>
  <keyword>S-amlodipine</keyword>
  <keyword>Pharmacokinetic</keyword>
  <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>Telmisartan</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/NCT02250833
org study id: 130HPS14006
nct id: NCT02250833
lead sponsor: 
has dmc: No
A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the
      pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration
      telmisartan and s-amlodipine in health volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
time frame: up to 168 hours post dose
measure: AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
time frame: up to 168 hours post dose
measure: Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
time frame: up to 168 hours post dose
measure: t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
time frame: up to 168 hours post dose
measure: AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
time frame: up to 168 hours post dose
measure: Number of participants with adverse events
time frame: up to 31days post dose
description: Adverse Event monitoring
Evaluated safety parameters included: Physical examination, Vital sign, ECG, laboratory test
arm group label: CKD-828(Fixed Dose Combination)
arm group type: Experimental
description: FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg
arm group label: Combination Therapy
arm group type: Active Comparator
description: Coadministration of Telmisartan 80mg and S-amlodipine 5mg
intervention type: Drug
intervention name: CKD-828
description: Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily
arm group label: CKD-828(Fixed Dose Combination)
other name: Telminuvo
intervention type: Drug
intervention name: Telmisartan
description: - Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine)
arm group label: Combination Therapy
other name: Micardis
intervention type: Drug
intervention name: S-amlodipine
description: - S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)
arm group label: Combination Therapy
other name: Anydipine s
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Young-Ran Yoon
role: Principal Investigator
affiliation: Kyungpook National University Hospital Clinical Trial Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Amlodipine
mesh term: Telmisartan