<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/NCT02205151</url>
  </required_header>
  <id_info>
    <org_study_id>BR-FAC-CT-101</org_study_id>
    <nct_id>NCT02205151</nct_id>
  </id_info>
  <brief_title>To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets</brief_title>
  <official_title>An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boryung Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kyunghee university hospital A Drug Analytical Laboratory</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>
      An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics&#xD;
      of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine&#xD;
      as Individual Tablets 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 A Group take fimasartan and amlodipine at 1st day and subjects of B&#xD;
      Group take fimasartan/amlodipine combination at 1st day.&#xD;
&#xD;
      And then, after wash out for 14 days, as period II, subjects of A Group take&#xD;
      fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and&#xD;
      amlodipine at 15th day.&#xD;
&#xD;
      At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,&#xD;
      3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36&#xD;
      times in total).&#xD;
&#xD;
      At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,&#xD;
      3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36&#xD;
      times in 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>(Cmax)</measure>
    <time_frame>0~144 hour after medication</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>(AUClast)</measure>
    <time_frame>0~144 hour after medication</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>(AUCinf)</measure>
    <time_frame>0~144 hour after medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>(tmax)</measure>
    <time_frame>0~144 hour after medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>(t1/2)</measure>
    <time_frame>0~144 hour after medication</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</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(14days) → Treatment B (1 day)&#xD;
Treatment A : Fimasartanm and Amlodipine&#xD;
Treatment B : Fimasartan/Amlodipine 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(14days) → Treatment A (1 day)&#xD;
Treatment A : Fimasartanm and Amlodipine&#xD;
Treatment B : Fimasartan/Amlodipine 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>Amlodipine</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/Amlodipine 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- 50 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. 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 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;
          2. History of clinically significant hypersensitivity to study drug, any other drug or&#xD;
             additives (yellow no.4).&#xD;
&#xD;
          3. Subject that is judged inappropriate for participating in the study based on physical&#xD;
             examination&#xD;
&#xD;
          4. The levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total&#xD;
             bilirubin &gt; 1.5 x the upper limit of normal or eGFR &lt; 60 mL/min/1.73m (calculated by&#xD;
             MDRD)&#xD;
&#xD;
          5. Evidence of hereditary disease, including galactose intolerance, Lapp lactase&#xD;
             deficiency, or glucose-galactose malabsorption.&#xD;
&#xD;
          6. systolic ≥ 140 mmHg or ≤ 100 mmHg, diastolic ≥ 90 mmHg or ≤ 65 mmHg), measured after&#xD;
             taking a rest for 5minutes&#xD;
&#xD;
          7. Take any other study's investigational products within 90 days prior to the first&#xD;
             administration of study drug&#xD;
&#xD;
          8. Donation of whole blood within 60 days prior to the first administration of study&#xD;
             drug, or donation of any blood products within 30 days prior to the first&#xD;
             administration of study drug&#xD;
&#xD;
          9. Intake food like Grapefruit juice (*e.g., Grapefruit juice ≥ 1L /day) within 7 days&#xD;
             prior to administration of study drug&#xD;
&#xD;
         10. Use of any prescribed drugs or herbal remedies within 14 days, or use of any&#xD;
             over-the-counter medication or vitamins within 7 days prior to the first&#xD;
             administration of study drug&#xD;
&#xD;
         11. Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)&#xD;
&#xD;
         12. Subject that is judged inappropriate for participating in the study by an&#xD;
             investigator, based any other reason&#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>seunghoon han, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Catholic university St. Mary hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Catholic university St. Mary hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</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>Amlodipine</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/NCT02205151
org study id: BR-FAC-CT-101
nct id: NCT02205151
lead sponsor: 
collaborator: 
has dmc: Yes
An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics
      of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine
      as Individual Tablets 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 A Group take fimasartan and amlodipine at 1st day and subjects of B
      Group take fimasartan/amlodipine combination at 1st day.

      And then, after wash out for 14 days, as period II, subjects of A Group take
      fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and
      amlodipine at 15th day.

      At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,
      3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36
      times in total).

      At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,
      3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36
      times in total).
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: (Cmax)
time frame: 0~144 hour after medication
measure: (AUClast)
time frame: 0~144 hour after medication
measure: (AUCinf)
time frame: 0~144 hour after medication
measure: (tmax)
time frame: 0~144 hour after medication
measure: (t1/2)
time frame: 0~144 hour after medication
arm group label: Treatment AB
arm group type: Other
description: Treatment A (1 day) → wash-out(14days) → Treatment B (1 day)
Treatment A : Fimasartanm and Amlodipine
Treatment B : Fimasartan/Amlodipine combination
arm group label: Treatment BA
arm group type: Other
description: Treatment B (1 day) → wash-out(14days) → Treatment A (1 day)
Treatment A : Fimasartanm and Amlodipine
Treatment B : Fimasartan/Amlodipine combination
intervention type: Drug
intervention name: Fimasartan
arm group label: Treatment AB
arm group label: Treatment BA
intervention type: Drug
intervention name: Amlodipine
arm group label: Treatment AB
arm group label: Treatment BA
intervention type: Drug
intervention name: Fimasartan/Amlodipine combination
arm group label: Treatment AB
arm group label: Treatment BA
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: seunghoon han, M.D., Ph.D.
role: Principal Investigator
affiliation: The Catholic university St. Mary hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Amlodipine