<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/NCT02967614</url>
  </required_header>
  <id_info>
    <org_study_id>KJ-TFC-004</org_study_id>
    <nct_id>NCT02967614</nct_id>
  </id_info>
  <brief_title>KJ-TFC-004 Drug-drug Interaction Study</brief_title>
  <official_title>A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Study to Evaluate the Drug-drugs Interaction Between Dorzolamide and Brimonidine in Healthy Korean Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kukje Pharma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kukje Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical trial to evaluate the influence of drug and drug-drug interactions of Brimonidine&#xD;
      and Dorzolamide co-administration on the pharmacokinetics of Brimonidine and pharmacokinetics&#xD;
      of Dorzolamide in healthy volunteers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentration of Brimonidine and Dorzolamide</measure>
    <time_frame>pre- and post dose of Brimonidine and Dorzolamide administration]</time_frame>
    <description>Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h,8d 0h(pre-dose), 8d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15 Point)&#xD;
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h, 100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point)&#xD;
Dorzolamide&#xD;
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25,0.5,0.75,1,1.5,2,2.5,3,4,8,12 h post-dose (Total 21Point)&#xD;
Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)&#xD;
Dorzolamide Period 1 : 1d 0h, 15d 0h, 29d 0h, 43d 0h, 57d 0h, 71d 0h, 85d 0h, 91d 0h, 91d 12h, 92d 0h (pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point)&#xD;
Period 2 : 93d 0h, 99d 0h, 99d 12h, 100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15Point)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trough concentration of Dorzolamide and N-Desethyl-Dorzloamide</measure>
    <time_frame>pre- and post dose of Dorzolamide and Dorzloamide administration]</time_frame>
    <description>Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h 8d 0h (pre-dose),8d 0.25,0.5,0.75,1,1.5,2,2.5,3, 4,8,12 h post-dose (Total 15Point)&#xD;
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)&#xD;
Dorzolamide&#xD;
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)&#xD;
Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h (pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)&#xD;
Dorzolamide Period 1 : 1d 0h,15d 0h,29d 0h,43d 0h,57d 0h,71d 0h,85d 0h,91d 0h, 91d 12h,92d 0h(pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)&#xD;
Period 1 : 93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Glaucoma</condition>
  <condition>Eye Diseases</condition>
  <condition>Ocular Hypertension</condition>
  <arm_group>
    <arm_group_label>[A]→[A]+[B]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 : At each dosing of Treatment A eye drops is administered for 8days&#xD;
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 92days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>[B]→[A]+[B]</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 : At each dosing of Treatment B eye drops is administered for 92days&#xD;
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 8days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[A]</intervention_name>
    <description>One eye drop(about 40ul) / Day1 ~ Day8 / BID</description>
    <arm_group_label>[A]→[A]+[B]</arm_group_label>
    <other_name>Brimonidine , Timolol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[B]</intervention_name>
    <description>One eye drop(about 40ul) / Day1 ~ Day92 / BID</description>
    <arm_group_label>[B]→[A]+[B]</arm_group_label>
    <other_name>Dorzolamide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[A]+[B](1)</intervention_name>
    <description>One eye drop(about 40ul) / Day9 ~ Day100 / BID</description>
    <arm_group_label>[A]→[A]+[B]</arm_group_label>
    <other_name>Brimonidine , Timolol , Dorzolamide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[A]+[B](2)</intervention_name>
    <description>One eye drop(about 40ul) / Day93 ~ Day100 / BID</description>
    <arm_group_label>[B]→[A]+[B]</arm_group_label>
    <other_name>Brimonidine , Timolol , Dorzolamide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male adults aged between 19 and 50 during screening period&#xD;
&#xD;
          -  BMI more than 18kg / m2 and less than 30kg / m2 and weight more than 55kg&#xD;
&#xD;
          -  Signed the informed consent form prior to study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of medical history or a concurrent disease that may interfere with treatment&#xD;
             and safety assessment or completion of this clinical study, including clinically&#xD;
             significant disorders in kidney, liver, cardiovascular system, respiratory system,&#xD;
             endocrine system, or neuropsychiatric system.&#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>Kyung-sang Yu, Ph.d., M.B.A</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Trial Center, Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Trial Center, Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 12, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</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>Eye Diseases</mesh_term>
    <mesh_term>Ocular Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Timolol</mesh_term>
    <mesh_term>Brimonidine Tartrate</mesh_term>
    <mesh_term>Dorzolamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02967614
org study id: KJ-TFC-004
nct id: NCT02967614
lead sponsor: 
has dmc: No
To assess the pharmacokinetic Interaction between Dorzolamide and Brimonidine in healthy male
      subjects.
Clinical trial to evaluate the influence of drug and drug-drug interactions of Brimonidine
      and Dorzolamide co-administration on the pharmacokinetics of Brimonidine and pharmacokinetics
      of Dorzolamide in healthy volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma concentration of Brimonidine and Dorzolamide
time frame: pre- and post dose of Brimonidine and Dorzolamide administration]
description: Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h,8d 0h(pre-dose), 8d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15 Point)
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h, 100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point)
Dorzolamide
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25,0.5,0.75,1,1.5,2,2.5,3,4,8,12 h post-dose (Total 21Point)
Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h(pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)
Dorzolamide Period 1 : 1d 0h, 15d 0h, 29d 0h, 43d 0h, 57d 0h, 71d 0h, 85d 0h, 91d 0h, 91d 12h, 92d 0h (pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 21Point)
Period 2 : 93d 0h, 99d 0h, 99d 12h, 100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12 h post-dose (Total 15Point)
measure: Trough concentration of Dorzolamide and N-Desethyl-Dorzloamide
time frame: pre- and post dose of Dorzolamide and Dorzloamide administration]
description: Group 1 Brimonidine Period 1 : 1d 0h,7d 0h,7d 12h 8d 0h (pre-dose),8d 0.25,0.5,0.75,1,1.5,2,2.5,3, 4,8,12 h post-dose (Total 15Point)
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)
Dorzolamide
Period 2 : 9d 0h,23d 0h,37d 0h,51d 0h,65d 0h,79d 0h,93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)
Group 2 Brimonidine Period 2 : 93d 0h,99d 0h,99d 12h,100d 0h (pre-dose),100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)
Dorzolamide Period 1 : 1d 0h,15d 0h,29d 0h,43d 0h,57d 0h,71d 0h,85d 0h,91d 0h, 91d 12h,92d 0h(pre-dose), 92d 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12h post-dose (Total 21Point)
Period 1 : 93d 0h,99d 0h,99d 12h,100d 0h (pre-dose), 100d 0.25, 0.5, 0.75, 1, 1.5,2,2.5,3,4,8,12h post-dose (Total 15Point)
arm group label: [A]→[A]+[B]
arm group type: Experimental
description: Period 1 : At each dosing of Treatment A eye drops is administered for 8days
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 92days
arm group label: [B]→[A]+[B]
arm group type: Experimental
description: Period 1 : At each dosing of Treatment B eye drops is administered for 92days
Period 2 : At each dosing of Treatment A + Treatment B eye drops is administered for 8days
intervention type: Drug
intervention name: [A]
description: One eye drop(about 40ul) / Day1 ~ Day8 / BID
arm group label: [A]→[A]+[B]
other name: Brimonidine , Timolol
intervention type: Drug
intervention name: [B]
description: One eye drop(about 40ul) / Day1 ~ Day92 / BID
arm group label: [B]→[A]+[B]
other name: Dorzolamide
intervention type: Drug
intervention name: [A]+[B](1)
description: One eye drop(about 40ul) / Day9 ~ Day100 / BID
arm group label: [A]→[A]+[B]
other name: Brimonidine , Timolol , Dorzolamide
intervention type: Drug
intervention name: [A]+[B](2)
description: One eye drop(about 40ul) / Day93 ~ Day100 / BID
arm group label: [B]→[A]+[B]
other name: Brimonidine , Timolol , Dorzolamide
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kyung-sang Yu, Ph.d., M.B.A
role: Principal Investigator
affiliation: Clinical Trial Center, Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Eye Diseases
mesh term: Ocular Hypertension
mesh term: Timolol
mesh term: Brimonidine Tartrate
mesh term: Dorzolamide
sharing ipd: No