<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/NCT01679847</url>
  </required_header>
  <id_info>
    <org_study_id>HSZL201001</org_study_id>
    <nct_id>NCT01679847</nct_id>
  </id_info>
  <brief_title>Blood Brain Barrier Penetration and Pharmacokinetics of the Elemene in Malignant Patients.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalian Holley Kingkong Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dalian Holley Kingkong Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier&#xD;
      penetration of the elemene.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <primary_completion_date type="Anticipated">April 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>blood and cerebrospinal fluid concentration</measure>
    <time_frame>0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Cancer</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma and Cerebrospinal fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        malignant patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histopathological or cytopathology diagnosis of malignancy&#xD;
&#xD;
          -  heart, liver and renal function is normal&#xD;
&#xD;
          -  Expected survival time is more than 3 months&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        exclusion Criteria:&#xD;
&#xD;
          -  non cancer patient&#xD;
&#xD;
          -  accepted elemene administration in 1 month&#xD;
&#xD;
          -  Expected survival time is less than 3 months&#xD;
&#xD;
          -  no Signed informed consent&#xD;
&#xD;
          -  heart, liver and renal function is abnormal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>liang xiaohua, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huashan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ZHAN QIONG, MD</last_name>
    <phone>8621-52887162</phone>
    <email>zjoan2121@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Huashan Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>September 7, 2012</last_update_submitted>
  <last_update_submitted_qc>September 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elemene</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>Blood-brain barrier</keyword>
  <!-- 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/NCT01679847
org study id: HSZL201001
nct id: NCT01679847
lead sponsor: 
has dmc: Yes
The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier
      penetration of the elemene.
observational model: Case-Only
measure: blood and cerebrospinal fluid concentration
time frame: 0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose
Plasma and Cerebrospinal fluid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: liang xiaohua, phD
role: Principal Investigator
affiliation: Huashan Hospital
last name: ZHAN QIONG, MD
phone: 8621-52887162
email: zjoan2121@gmail.com
facility: 
country: China
responsible party type: Sponsor