<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/NCT03293277</url>
  </required_header>
  <id_info>
    <org_study_id>HR0171401-101</org_study_id>
    <nct_id>NCT03293277</nct_id>
  </id_info>
  <brief_title>Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects</brief_title>
  <official_title>A Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</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>
      The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of&#xD;
      intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and&#xD;
      intravenously administered dexmedetomidine in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Baseline to 7 days after dose administration</time_frame>
    <description>Number of subjects with adverse events</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>A1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>80µg Dexmedetomidine or Placebo is administered intranasally on Day 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal Dexmedetomidine</intervention_name>
    <description>Intranasal Dexmedetomidine</description>
    <arm_group_label>A1</arm_group_label>
    <arm_group_label>A2</arm_group_label>
    <arm_group_label>B1</arm_group_label>
    <arm_group_label>B2</arm_group_label>
    <arm_group_label>C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Dexmedetomidine</intervention_name>
    <description>Intravenous Dexmedetomidine</description>
    <arm_group_label>A1</arm_group_label>
    <arm_group_label>A2</arm_group_label>
    <arm_group_label>B1</arm_group_label>
    <arm_group_label>B2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal Placebo</intervention_name>
    <description>Intranasal Placebo</description>
    <arm_group_label>A1</arm_group_label>
    <arm_group_label>A2</arm_group_label>
    <arm_group_label>B1</arm_group_label>
    <arm_group_label>B2</arm_group_label>
    <arm_group_label>C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Placebo</intervention_name>
    <description>Intravenous Placebo</description>
    <arm_group_label>A1</arm_group_label>
    <arm_group_label>A2</arm_group_label>
    <arm_group_label>B1</arm_group_label>
    <arm_group_label>B2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult male 18 - 40 years of age&#xD;
&#xD;
          -  Body weight &gt;/= 50 kg (male) or &gt;/= 45 kg (female), with BMI between 19.0 and 26.0&#xD;
             kg/m2, inclusive&#xD;
&#xD;
          -  Capable of giving written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant disease or conditions that may place the subject at&#xD;
             unacceptable risk as a participant in the study, or that may interfere with the&#xD;
             safety, tolerability or pharmacodynamic evaluations in the study&#xD;
&#xD;
          -  Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C&#xD;
             virus antibody; positive drug or alcohol test&#xD;
&#xD;
          -  Major surgery within 4 weeks of screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shirley Cai, MD</last_name>
    <phone>18036618138</phone>
    <email>caixiaoli@shhrp.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Huang</last_name>
      <phone>15116469024</phone>
      <email>cellahuang1988@163.com</email>
    </contact>
    <investigator>
      <last_name>Guoping Yang, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wen Ouyang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>January 18, 2018</last_update_submitted>
  <last_update_submitted_qc>January 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT03293277
org study id: HR0171401-101
nct id: NCT03293277
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of
      intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and
      intravenously administered dexmedetomidine in healthy volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse Events
time frame: Baseline to 7 days after dose administration
description: Number of subjects with adverse events
arm group label: A1
arm group type: Experimental
description: 20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
arm group label: A2
arm group type: Experimental
description: 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8
arm group label: B1
arm group type: Experimental
description: 40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
arm group label: B2
arm group type: Experimental
description: 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8
arm group label: C
arm group type: Experimental
description: 80µg Dexmedetomidine or Placebo is administered intranasally on Day 1
intervention type: Drug
intervention name: Intranasal Dexmedetomidine
description: Intranasal Dexmedetomidine
arm group label: A1
arm group label: A2
arm group label: B1
arm group label: B2
arm group label: C
intervention type: Drug
intervention name: Intravenous Dexmedetomidine
description: Intravenous Dexmedetomidine
arm group label: A1
arm group label: A2
arm group label: B1
arm group label: B2
intervention type: Drug
intervention name: Intranasal Placebo
description: Intranasal Placebo
arm group label: A1
arm group label: A2
arm group label: B1
arm group label: B2
arm group label: C
intervention type: Drug
intervention name: Intravenous Placebo
description: Intravenous Placebo
arm group label: A1
arm group label: A2
arm group label: B1
arm group label: B2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shirley Cai, MD
phone: 18036618138
email: caixiaoli@shhrp.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Dexmedetomidine