NCT02384720Unknown不适用
Study of Freefol-MCT PKPD in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Non- compartment pharmacokinetic parameters
研究概览
简要总结
The purpose of this study is to analysis PKPD of Freefol-MCT and to investigate relationship between the concentration of Freefol-MCT and the index which signaly analyzes those: EEG, EEG approximate entropy, systolic BP, saturation wave form and invasive BP wave form.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults males/Females aged over 20years
- •Health screening examination within 60 days of the start (Interview, vital signs , 12-lead ECG, blood tests, urinalysis) .
- •The applicant who agreed in writing by told an explanation enough about the characteristics of the study drug, the purpose of the test and the details.
排除标准
- •Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.)
- •Who had acute disease or organ dysfunction within four weeks of the start of the test.
- •Who had significant hematologic disorders or donate whole blood within two months of the start of the test.
- •Significant neuropsychiatric or more.
- •Continued drug abuse.
- •Who has a history of drug and other hypersensitivity reactions.
- •Positive at Type B / C hepatitis , syphilis tests (VDRL), if in AIDS antibody test
- •Who took other clinical medicine within two months of the start of the test.
- •Who smokes or drinks within two weeks after dosing.
- •Who takes drugs regularly other than the mineral claim or vitamin. However, it depends on judgment of the researchers.
结局指标
主要结局
Non- compartment pharmacokinetic parameters
时间窗: 1200 minutes
Ce50
时间窗: 1200 minutes
SBP
时间窗: 1200 minutes
E0
时间窗: 1200 minutes
Emax
时间窗: 1200 minutes
ke0
时间窗: 1200 minutes
Compartment pharmacokinetic parameters
时间窗: 1200 minutes
BIS
时间窗: 1200 minutes
次要结局
未报告次要终点
研究者
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