Cancer Clinical Trial
The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene.
| Status | Not yet recruiting |
| Enrollment | 8 |
| Est. completion date | June 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Observational Model: Case-Only
| Country | Name | City | State |
|---|---|---|---|
| China | Huashan Hospital of Fudan University | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Dalian Holley Kingkong Pharmaceutical Co., Ltd |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | blood and cerebrospinal fluid concentration | 0,0.25,0.5,1,1.5,2,3,3.5,4,6,8,12 hours post dose | No |
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