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

This study is not yet open for participant recruitment.
Verified September 2012 by Dalian Holley Kingkong Pharmaceutical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Dalian Holley Kingkong Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01679847
First received: September 3, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 of Fudan University
  More Information

No publications provided

Responsible Party: Dalian Holley Kingkong Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01679847     History of Changes
Other Study ID Numbers: HSZL201001
Study First Received: September 3, 2012
Last Updated: September 7, 2012
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013