<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/NCT02233218</url>
  </required_header>
  <id_info>
    <org_study_id>YH22189-101</org_study_id>
    <nct_id>NCT02233218</nct_id>
  </id_info>
  <brief_title>The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers</brief_title>
  <official_title>A Phase 1, Open Label, Non-randomized, Two-cohort, Single-sequence, Crossover Study to Investigate the Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuhan Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuhan Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the pharmacokinetic Drug-drug interaction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan,&#xD;
      amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma/serum/blood drug concentration-time curve in steady-state of Telmisartan and Amlodipine</measure>
    <time_frame>0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine</measure>
    <time_frame>0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma/serum/blood drug concentration-time curve in steady-state of Rosuvastatin</measure>
    <time_frame>0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin</measure>
    <time_frame>0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of peak concentration in steady state of Telmisartan and Amlodipine</measure>
    <time_frame>0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine</measure>
    <time_frame>0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma/serum/blood drug concentration-time curve in steady-state of N- desmethyl rosuvastatin</measure>
    <time_frame>0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration of drug in plasma/serum/blood in steady-state of N- desmethyl rosuvastatin</measure>
    <time_frame>0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of peak concentration in steady state of rosuvastatin and N- desmethyl rosuvastatin</measure>
    <time_frame>0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin and N- desmethyl rosuvastatin</measure>
    <time_frame>0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy Male Volunteer</condition>
  <arm_group>
    <arm_group_label>telmisartan, Amlodipine, Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm is consist of 40 subjects. Telmisartan80mg + Amlodipine 10mg 9 days, Telmisartan80mg + Amlodipine 10mg , Rosuvastatin 20mg 5days Total 14days administration of investigational products to healthy male volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan, Amlodipine, Rosuvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm is consist of 20 subjects. Rosuvastatin 20mg 5 days, Rosuvastatin 20mg , Telmisartan80mg + Amlodipine 10mg 9days, Total 14days administration of investigational products to healthy male volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telmisartan</intervention_name>
    <arm_group_label>Telmisartan, Amlodipine, Rosuvastatin</arm_group_label>
    <arm_group_label>telmisartan, Amlodipine, Rosuvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine</intervention_name>
    <arm_group_label>Telmisartan, Amlodipine, Rosuvastatin</arm_group_label>
    <arm_group_label>telmisartan, Amlodipine, Rosuvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <arm_group_label>Telmisartan, Amlodipine, Rosuvastatin</arm_group_label>
    <arm_group_label>telmisartan, Amlodipine, Rosuvastatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male volunteers aged 19 to 50&#xD;
&#xD;
          2. Participant who has a body weight that is &gt;=55kg(male) and body mass index (BMI) level&#xD;
             that is 18~30&#xD;
&#xD;
          3. Provision of signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of clinically significant disease&#xD;
&#xD;
          2. History of clinically significant hypersensitivity or hypersensitivity reactions to&#xD;
             drugs and other medications (aspirin, antibiotics, etc.), including components such as&#xD;
             Telmisartan, Rosuvastatin and Amlodipine&#xD;
&#xD;
          3. A history of drug abuse or the presence of positive reactions to drugs that have abuse&#xD;
             potential in urine screenings for drugs&#xD;
&#xD;
          4. Administration of other investigational products within 2 months prior to the first&#xD;
             dosing.&#xD;
&#xD;
          5. Administration of herbal medicine within 2 weeks or administration of ethical drugs&#xD;
             within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior&#xD;
             to the first dosing of the investigational product (if the investigator (study doctor)&#xD;
             determines that the person meets other criteria appropriately, the relevant person may&#xD;
             participate in the study)&#xD;
&#xD;
          6. Volunteers considered not eligible for the clinical trial by the investigator (study&#xD;
             doctor) due to the reasons including laboratory test results, ECGs, or vital signs.&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Minkgyu Park, Ph.D, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dong-A university hospital of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dong-A university hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>February 16, 2015</last_update_submitted>
  <last_update_submitted_qc>February 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Telmisartan</mesh_term>
    <mesh_term>Rosuvastatin Calcium</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/NCT02233218
org study id: YH22189-101
nct id: NCT02233218
lead sponsor: 
has dmc: No
To investigate the pharmacokinetic Drug-drug interaction
The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan,
      amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Area under the plasma/serum/blood drug concentration-time curve in steady-state of Telmisartan and Amlodipine
time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Maximum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine
time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Area under the plasma/serum/blood drug concentration-time curve in steady-state of Rosuvastatin
time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Maximum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin
time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Time of peak concentration in steady state of Telmisartan and Amlodipine
time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Minimum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine
time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Area under the plasma/serum/blood drug concentration-time curve in steady-state of N- desmethyl rosuvastatin
time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Maximum concentration of drug in plasma/serum/blood in steady-state of N- desmethyl rosuvastatin
time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Time of peak concentration in steady state of rosuvastatin and N- desmethyl rosuvastatin
time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
measure: Minimum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin and N- desmethyl rosuvastatin
time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
arm group label: telmisartan, Amlodipine, Rosuvastatin
arm group type: Experimental
description: This arm is consist of 40 subjects. Telmisartan80mg + Amlodipine 10mg 9 days, Telmisartan80mg + Amlodipine 10mg , Rosuvastatin 20mg 5days Total 14days administration of investigational products to healthy male volunteers
arm group label: Telmisartan, Amlodipine, Rosuvastatin
arm group type: Experimental
description: This arm is consist of 20 subjects. Rosuvastatin 20mg 5 days, Rosuvastatin 20mg , Telmisartan80mg + Amlodipine 10mg 9days, Total 14days administration of investigational products to healthy male volunteers
intervention type: Drug
intervention name: Telmisartan
arm group label: Telmisartan, Amlodipine, Rosuvastatin
arm group label: telmisartan, Amlodipine, Rosuvastatin
intervention type: Drug
intervention name: Amlodipine
arm group label: Telmisartan, Amlodipine, Rosuvastatin
arm group label: telmisartan, Amlodipine, Rosuvastatin
intervention type: Drug
intervention name: Rosuvastatin
arm group label: Telmisartan, Amlodipine, Rosuvastatin
arm group label: telmisartan, Amlodipine, Rosuvastatin
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Minkgyu Park, Ph.D, M.D.
role: Principal Investigator
affiliation: Dong-A university hospital of Korea
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Amlodipine
mesh term: Telmisartan
mesh term: Rosuvastatin Calcium