<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/NCT03252067</url>
  </required_header>
  <id_info>
    <org_study_id>TR-PK-201402</org_study_id>
    <nct_id>NCT03252067</nct_id>
  </id_info>
  <brief_title>Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers</brief_title>
  <official_title>Tear Concentrations and Pharmacokinetics of Azithromycin Following Topical Administration of a Single Dose of Azithromycin Eyedrops in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tongren Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grand Pharmaceutical (China) Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Tongren Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops&#xD;
      (2.5ml/25mg) in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized, open, single-center study, 42 healthy volunteers will receive one drop of&#xD;
      azithromycin into each eye. Azithromycin tear concentrations will be measured by LC-MS/MS at&#xD;
      seven time points for 24 hours. Tolerability is evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 31, 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the maximum concentration (Cmax)</measure>
    <time_frame>The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.</time_frame>
    <description>The tear samples are taken at 7 time points after administration up to 24 hours.The Cmax is calculated at the average concentration of each point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>area under the curve (AUC)</measure>
    <time_frame>The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.</time_frame>
    <description>The tear samples are taken at 7 time points after administration up to 24 hours.The AUC is calculated at the average concentration of each point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AEs</measure>
    <time_frame>24 hours</time_frame>
    <description>Ocular and systemic adverse events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>azithromycin eyedrop</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each of the subjects' eyes will receive single dose of azithromycin eyedrops and then attribute the time for tear sampling at seven time points up to 24 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>azithromycin eyedrop</intervention_name>
    <description>Tear samples will be collected using the strips.</description>
    <arm_group_label>azithromycin eyedrop</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 45 years old, male or female;&#xD;
&#xD;
          -  BMI in the range of 19 to 24;&#xD;
&#xD;
          -  eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and&#xD;
             fundus examination were normal, tear secretion function is normal;&#xD;
&#xD;
          -  Good compliance and voluntarily signed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have eye disease or systemic disease;&#xD;
&#xD;
          -  physical examination, laboratory tests, ECG and chest X-ray examination abnormalities&#xD;
             and has clinical significance;&#xD;
&#xD;
          -  HBsAg, anti-HCV, anti-HIV and TPPA positive;&#xD;
&#xD;
          -  those who used eye drops two weeks before the test and who used any dosage form of&#xD;
             azithromycin;&#xD;
&#xD;
          -  known to azithromycin or macrolide-related varieties of allergies or serious adverse&#xD;
             reactions;&#xD;
&#xD;
          -  need to wear contact lenses during the test;&#xD;
&#xD;
          -  history of internal surgery or laser surgery history;&#xD;
&#xD;
          -  participated in other drug clinical trials in the past three months;&#xD;
&#xD;
          -  pregnant women and lactating women, or in the growth period without taking effective&#xD;
             contraceptive measures, menstrual period women;&#xD;
&#xD;
          -  mental illness or alcohol, history of drug abuse or inability to collaborate;&#xD;
&#xD;
          -  Any other circumstances that the investigators consider are unfit to participate in&#xD;
             this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Feng Wu, Master</last_name>
    <phone>010-58268486</phone>
    <email>trdrug@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Tongren Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Wu</last_name>
      <phone>010-58268486</phone>
      <email>trdrug@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tongren Hospital</investigator_affiliation>
    <investigator_full_name>Xiuli Zhao</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Azithromycin eyedrops, pharmacokinetics, tears</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Ophthalmic Solutions</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/NCT03252067
org study id: TR-PK-201402
nct id: NCT03252067
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops
      (2.5ml/25mg) in healthy volunteers.
In this randomized, open, single-center study, 42 healthy volunteers will receive one drop of
      azithromycin into each eye. Azithromycin tear concentrations will be measured by LC-MS/MS at
      seven time points for 24 hours. Tolerability is evaluated.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the maximum concentration (Cmax)
time frame: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
description: The tear samples are taken at 7 time points after administration up to 24 hours.The Cmax is calculated at the average concentration of each point.
measure: area under the curve (AUC)
time frame: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
description: The tear samples are taken at 7 time points after administration up to 24 hours.The AUC is calculated at the average concentration of each point.
measure: AEs
time frame: 24 hours
description: Ocular and systemic adverse events
arm group label: azithromycin eyedrop
arm group type: Experimental
description: Each of the subjects' eyes will receive single dose of azithromycin eyedrops and then attribute the time for tear sampling at seven time points up to 24 hours.
intervention type: Drug
intervention name: azithromycin eyedrop
description: Tear samples will be collected using the strips.
arm group label: azithromycin eyedrop
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Feng Wu, Master
phone: 010-58268486
email: trdrug@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tongren Hospital
investigator full name: Xiuli Zhao
investigator title: Prof.
mesh term: Azithromycin
mesh term: Ophthalmic Solutions
sharing ipd: No