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Blood Brain Barrier Penetration and Pharmacokinetics of the Elemene in Malignant Patients.

Sponsor
Dalian Holley Kingkong Pharmaceutical Co., Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01679847
Collaborator
(none)
8
Enrollment
1
Location
9
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    8 participants
    Observational Model:
    Case-Only
    Study Start Date :
    Sep 1, 2012
    Anticipated Primary Completion Date :
    Apr 1, 2013
    Anticipated Study Completion Date :
    Jun 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. blood and cerebrospinal fluid concentration [0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • histopathological or cytopathology diagnosis of malignancy

    • heart, liver and renal function is normal

    • Expected survival time is more than 3 months

    • Signed informed consent

    exclusion Criteria:

    • non cancer patient

    • accepted elemene administration in 1 month

    • Expected survival time is less than 3 months

    • no Signed informed consent

    • heart, liver and renal function is abnormal

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Huashan Hospital of Fudan University Shanghai Shanghai China 200040

    Sponsors and Collaborators

    • Dalian Holley Kingkong Pharmaceutical Co., Ltd

    Investigators

    • Principal Investigator: liang xiaohua, phD, Huashan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dalian Holley Kingkong Pharmaceutical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT01679847
    Other Study ID Numbers:
    • HSZL201001
    First Posted:
    Sep 6, 2012
    Last Update Posted:
    Sep 10, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by Dalian Holley Kingkong Pharmaceutical Co., Ltd
    Elemene
    pharmacokinetics
    Blood-brain barrier

    Study Results

    No Results Posted as of Sep 10, 2012