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

September 7, 2012 updated by: Dalian Holley Kingkong Pharmaceutical Co., Ltd
The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

malignant patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalian Holley Kingkong Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: liang xiaohua, phD, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

September 3, 2012

First Submitted That Met QC Criteria

September 3, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 7, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSZL201001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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