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

• Conditions: Cancer

• Registration Number: NCT01679847
• Lead Sponsor: Dalian Holley Kingkong Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-06
• Last Update Submitted: 2012-09-07
• Last Update Posted: 2012-09-10
• Primary Completion: 2013-04
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood and cerebrospinal fluid concentration	0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose

Trial Locations

Locations (1)

Huashan Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China