NCT01679847UnknownNot Applicable
Blood Brain Barrier Penetration and Pharmacokinetics of the Elemene in Malignant Patients.
Dalian Holley Kingkong Pharmaceutical Co., Ltd1 site in 1 country8 target enrollmentStarted: September 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- blood and cerebrospinal fluid concentration
Study Overview
Brief Summary
The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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