<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/NCT02205190</url>
  </required_header>
  <id_info>
    <org_study_id>BR-FRC-CT-101</org_study_id>
    <nct_id>NCT02205190</nct_id>
  </id_info>
  <brief_title>to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin</brief_title>
  <official_title>A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boryung Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boryung Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A phase I clinical trial to compare the pharmacokinetics and safety of&#xD;
      fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and&#xD;
      rosuvastatin in healthy male volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After subjects have signed informed consent voluntarily, they go through screening period for&#xD;
      within 21 days.&#xD;
&#xD;
      As period I, subjects of 1 Group take fimasartan and rosuvastatin at 1st day and subjects of&#xD;
      2 Group take fimasartan/rosuvastatin combination at 1st day.&#xD;
&#xD;
      And then, after wash out for 7 days, as period II, subjects of 1 Group take&#xD;
      fimasartan/rosuvastatin combination at 8th day and subjects of 2 Group take fimasartan and&#xD;
      rosuvastatin at 8th day.&#xD;
&#xD;
      At each period, subjects of 1 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,&#xD;
      4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in&#xD;
      total).&#xD;
&#xD;
      At each period, subjects of 2 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,&#xD;
      4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in&#xD;
      total).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>(AUClast)</measure>
    <time_frame>0~72 hour after medication</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>(Cmax)</measure>
    <time_frame>0~72 hour after medication</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>(AUCinf)</measure>
    <time_frame>0~72 hour after medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>(tmax)</measure>
    <time_frame>0~72 hour after medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>(t1/2)</measure>
    <time_frame>0~72 hour after medication</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Treatment AB</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment A (1 day) → wash-out(7days) → Treatment B (1 day)&#xD;
Treatment A : Fimasartan and Rosuvastatin&#xD;
Treatment B : Fimasartan/Rosuvastatin combination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment BA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment B (1 day) → wash-out(7days) → Treatment A (1 day)&#xD;
Treatment A : Fimasartan and Rosuvastatin&#xD;
Treatment B : Fimasartan/Rosuvastatin combination</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fimasartan</intervention_name>
    <arm_group_label>Treatment AB</arm_group_label>
    <arm_group_label>Treatment BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <arm_group_label>Treatment AB</arm_group_label>
    <arm_group_label>Treatment BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fimasartan/Rosuvastatin combination</intervention_name>
    <arm_group_label>Treatment AB</arm_group_label>
    <arm_group_label>Treatment BA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male subject, aged 19- 55 years at screening.&#xD;
&#xD;
          2. Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm)&#xD;
             - 100} * 0.9&#xD;
&#xD;
          3. No abnormal symptom or sign, based on medical history and physical examination, with&#xD;
             no congenital or chronic disease that requires treatment&#xD;
&#xD;
          4. Subject that is considered appropriate for participating in the study by an&#xD;
             investigator, based on clinical laboratory test (serology, hematology, clinical&#xD;
             chemistry, urinalysis) and ECG, performed within 3 weeks prior to administration of&#xD;
             study drug&#xD;
&#xD;
          5. Subjects must be able to listen to and understand the detailed statement of informed&#xD;
             consent, and willing to decide to participate in the study, follow the study&#xD;
             directions and provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of clinically significant hypersensitivity to study drug, any other drug or&#xD;
             additives (yellow no.5).&#xD;
&#xD;
          2. History of any illness that may affect the absorption, distribution, metabolism or&#xD;
             excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism),&#xD;
             respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric&#xD;
             and musculoskeletal system)&#xD;
&#xD;
          3. Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥&#xD;
             140 mmHg or diastolic ≥ 90 mmHg), measured at screening&#xD;
&#xD;
          4. Active liver disease, or the levels of ALT(Aspartate Transaminase), AST (Alanin&#xD;
             Transaminase) or total bilirubin &gt; 1.5 x the upper limit of normal&#xD;
&#xD;
          5. Creatinine clearance &lt; 60 mL/min (calculated by Cockcroft-Gault formula using serum&#xD;
             creatinine)&#xD;
&#xD;
          6. Evidence of hereditary disease, including galactose intolerance, Lapp lactase&#xD;
             deficiency, or glucose-galactose malabsorption.&#xD;
&#xD;
          7. History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or&#xD;
             resection operation that may affect the absorption of the study drug (excluding simple&#xD;
             appendectomy or herniorrhaphy)&#xD;
&#xD;
          8. History of major injury, surgical operation, or suspected symptom of acute illness&#xD;
             (severe infection, trauma, diarrhea or vomiting) within 4 weeks prior to the first&#xD;
             administration of study drug&#xD;
&#xD;
          9. History of excessive alcohol abuse (&gt;21 units/week, 1 unit=10g=12.5mL of pure&#xD;
             alcohol), or subjects who cannot abstain from drinking for at least 3 days prior to&#xD;
             the start of this study and throughout the study period, or excessive smoking (&gt;10&#xD;
             cigarettes/day)&#xD;
&#xD;
         10. Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any&#xD;
             over-the-counter medication within 1 week prior to the first administration of study&#xD;
             drug, and this will affect this study or the safety of the subjects in the opinion of&#xD;
             the investigator&#xD;
&#xD;
         11. Participation in any other study within 3 months prior to the first administration of&#xD;
             study drug (The finish time of previous study is the day of the last administration of&#xD;
             study drug)&#xD;
&#xD;
         12. Donation of whole blood within 2 months prior to the first administration of study&#xD;
             drug, or donation of any blood products within 1 month prior to the first&#xD;
             administration of study drug&#xD;
&#xD;
         13. Abnormal diet that may affect absorption, distribution, metabolism and excretion of&#xD;
             drugs (*e.g., Grapefruit juice ≥ 1L /day within 7 days prior to administration of&#xD;
             study drug)&#xD;
&#xD;
         14. Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)&#xD;
&#xD;
         15. Subject that is judged inappropriate for participating in the study by an&#xD;
             investigator, based on clinical laboratory test (serology, hematology, clinical&#xD;
             chemistry, urinalysis) or any other reason&#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>youngran yoon, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyungpook National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>October 13, 2014</last_update_submitted>
  <last_update_submitted_qc>October 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fimasartan</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>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/NCT02205190
org study id: BR-FRC-CT-101
nct id: NCT02205190
lead sponsor: 
collaborator: 
has dmc: Yes
A phase I clinical trial to compare the pharmacokinetics and safety of
      fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and
      rosuvastatin in healthy male volunteers
After subjects have signed informed consent voluntarily, they go through screening period for
      within 21 days.

      As period I, subjects of 1 Group take fimasartan and rosuvastatin at 1st day and subjects of
      2 Group take fimasartan/rosuvastatin combination at 1st day.

      And then, after wash out for 7 days, as period II, subjects of 1 Group take
      fimasartan/rosuvastatin combination at 8th day and subjects of 2 Group take fimasartan and
      rosuvastatin at 8th day.

      At each period, subjects of 1 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,
      4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in
      total).

      At each period, subjects of 2 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,
      4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in
      total).
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: (AUClast)
time frame: 0~72 hour after medication
measure: (Cmax)
time frame: 0~72 hour after medication
measure: (AUCinf)
time frame: 0~72 hour after medication
measure: (tmax)
time frame: 0~72 hour after medication
measure: (t1/2)
time frame: 0~72 hour after medication
arm group label: Treatment AB
arm group type: Other
description: Treatment A (1 day) → wash-out(7days) → Treatment B (1 day)
Treatment A : Fimasartan and Rosuvastatin
Treatment B : Fimasartan/Rosuvastatin combination
arm group label: Treatment BA
arm group type: Other
description: Treatment B (1 day) → wash-out(7days) → Treatment A (1 day)
Treatment A : Fimasartan and Rosuvastatin
Treatment B : Fimasartan/Rosuvastatin combination
intervention type: Drug
intervention name: Fimasartan
arm group label: Treatment AB
arm group label: Treatment BA
intervention type: Drug
intervention name: Rosuvastatin
arm group label: Treatment AB
arm group label: Treatment BA
intervention type: Drug
intervention name: Fimasartan/Rosuvastatin combination
arm group label: Treatment AB
arm group label: Treatment BA
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: youngran yoon, M.D., Ph.D.
role: Principal Investigator
affiliation: Kyungpook National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Rosuvastatin Calcium