<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/NCT03235141</url>
  </required_header>
  <id_info>
    <org_study_id>ESSEX-AOS-PK-2001</org_study_id>
    <nct_id>NCT03235141</nct_id>
  </id_info>
  <brief_title>Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers</brief_title>
  <official_title>Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tongren Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhuhai Essex Bio-Pharmaceutical Company Limited</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Panacea Technologies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Tongren Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the&#xD;
      original azithromycin eye drops, and evaluate the release behavior of both in the eye.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are 48 patients will divided into group A and group B randomly . subjects of Group A&#xD;
      will given the first test drug, elution after the control drug; Subjects of Group B will&#xD;
      given the first control drug, elution given to the test drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 7, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 30, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>There are 8 subjects will be enrolled in pre-test, each subject was sampled in two eyes and each subject participated in two cycles of the trial. 8 subjects, 16 eyes participated in the study, 32 samples of tears total .&#xD;
There are 48 subjects will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-t</measure>
    <time_frame>The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours</time_frame>
    <description>The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The AUC of the test drug and the control drug was calculated at the average concentration of each point</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours</time_frame>
    <description>The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The Cmax of the test drug and the control drug was calculated at the average concentration of each point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE</measure>
    <time_frame>from the ICF signed to the end of the trial,through study completion, an average of 1 year</time_frame>
    <description>compared the laboratory test values before and after treatment,according to the study drug use, calculate the number of cases, the number of cases and the incidence of adverse reactions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SAE</measure>
    <time_frame>from the ICF signed to the end of the trial,through study completion, an average of 1 year</time_frame>
    <description>Any serious adverse events that occur during the clinical study, whether or not related to the drug should be collected.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Bacterial Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>azithromycin eye drops by essex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In one cycle, give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the AzaSite eye drops,2.5ml/25mg，1 drop，once.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AzaSite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In one cycle, give the AzaSite eye drops,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>azithromycin eye drops by essex</intervention_name>
    <description>azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),</description>
    <arm_group_label>AzaSite</arm_group_label>
    <arm_group_label>azithromycin eye drops by essex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>azithromycin eye drops</intervention_name>
    <description>azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc</description>
    <arm_group_label>AzaSite</arm_group_label>
    <arm_group_label>azithromycin eye drops by essex</arm_group_label>
    <other_name>AzaSite</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 65 years old, male or female;&#xD;
&#xD;
          -  BMI in the range of 19 to 28;&#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 and HIV 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>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiuli Zhao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tongren Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiuli Zhao, Doctor</last_name>
    <phone>+86-13911901818</phone>
    <email>XL_Zhao_YLJD@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Siyang Ni, Doctor</last_name>
    <phone>+86-18911810275</phone>
    <email>grandnsy@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Tongren Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Wu</last_name>
      <phone>010-58268422</phone>
      <email>trdrug@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 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>Director of Phase I Clinical Trial Center</investigator_title>
  </responsible_party>
  <keyword>Azithromycin eye drops</keyword>
  <keyword>Local Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conjunctivitis, Bacterial</mesh_term>
    <mesh_term>Conjunctivitis</mesh_term>
  </condition_browse>
  <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>
  <pending_results>
    <submitted>July 25, 2022</submitted>
    <returned>June 30, 2023</returned>
  </pending_results>
  <!-- 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/NCT03235141
org study id: ESSEX-AOS-PK-2001
nct id: NCT03235141
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the
      original azithromycin eye drops, and evaluate the release behavior of both in the eye.
There are 48 patients will divided into group A and group B randomly . subjects of Group A
      will given the first test drug, elution after the control drug; Subjects of Group B will
      given the first control drug, elution given to the test drug.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: There are 8 subjects will be enrolled in pre-test, each subject was sampled in two eyes and each subject participated in two cycles of the trial. 8 subjects, 16 eyes participated in the study, 32 samples of tears total .
There are 48 subjects will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: AUC0-t
time frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
description: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The AUC of the test drug and the control drug was calculated at the average concentration of each point
measure: Cmax
time frame: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours
description: The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours，The Cmax of the test drug and the control drug was calculated at the average concentration of each point
measure: AE
time frame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
description: compared the laboratory test values before and after treatment,according to the study drug use, calculate the number of cases, the number of cases and the incidence of adverse reactions.
measure: SAE
time frame: from the ICF signed to the end of the trial,through study completion, an average of 1 year
description: Any serious adverse events that occur during the clinical study, whether or not related to the drug should be collected.
arm group label: azithromycin eye drops by essex
arm group type: Experimental
description: In one cycle, give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the AzaSite eye drops,2.5ml/25mg，1 drop，once.
arm group label: AzaSite
arm group type: Active Comparator
description: In one cycle, give the AzaSite eye drops,2.5ml/25mg，1 drop，once. In the second cycle(after 14 days elution）,give the azithromycin eye drops by essex,2.5ml/25mg，1 drop，once.
intervention type: Drug
intervention name: azithromycin eye drops by essex
description: azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),
arm group label: AzaSite
arm group label: azithromycin eye drops by essex
intervention type: Drug
intervention name: azithromycin eye drops
description: azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc
arm group label: AzaSite
arm group label: azithromycin eye drops by essex
other name: AzaSite
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiuli Zhao
role: Principal Investigator
affiliation: Beijing Tongren Hospital
last name: Xiuli Zhao, Doctor
phone: +86-13911901818
email: XL_Zhao_YLJD@163.com
last name: Siyang Ni, Doctor
phone: +86-18911810275
email: grandnsy@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tongren Hospital
investigator full name: Xiuli Zhao
investigator title: Director of Phase I Clinical Trial Center
mesh term: Conjunctivitis, Bacterial
mesh term: Conjunctivitis
mesh term: Azithromycin
mesh term: Ophthalmic Solutions
sharing ipd: No
submitted: July 25, 2022
returned: June 30, 2023