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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Dalian Holley Kingkong Pharmaceutical Co., Ltd.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679847
First Posted: September 6, 2012
Last Update Posted: September 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dalian Holley Kingkong Pharmaceutical Co., Ltd
  Purpose
The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene.

Condition Phase
Cancer Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only

Further study details as provided by Dalian Holley Kingkong Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
Plasma and Cerebrospinal fluid

Estimated Enrollment: 8
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
malignant patients
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679847


Contacts
Contact: ZHAN QIONG, MD 8621-52887162 zjoan2121@gmail.com

Locations
China, Shanghai
Huashan Hospital of Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Dalian Holley Kingkong Pharmaceutical Co., Ltd
Investigators
Principal Investigator: liang xiaohua, phD Huashan Hospital
  More Information

Responsible Party: Dalian Holley Kingkong Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01679847     History of Changes
Other Study ID Numbers: HSZL201001
First Submitted: September 3, 2012
First Posted: September 6, 2012
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by Dalian Holley Kingkong Pharmaceutical Co., Ltd:
Elemene
pharmacokinetics
Blood-brain barrier