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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:
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
  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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679847

Locations
China, Shanghai
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
  More Information

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 December 06, 2016