ISRCTN74386009已完成不适用
Single centre, double-blind, randomised, placebo-controlled, two-fold cross-over, drug cocktail phenotyping study on the in vivo interaction potential of Silexan (WS® 1265) with respect to the activities of cytochrome P-450 enzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) in healthy volunteers
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 16 人开始时间: 2009年12月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Willing and capable to confirm written consent
- •2. Caucasian male or female
- •3. Aged between 18 - 55 years
- •4. A body mass index (BMI) 19 - 29 kg/m^2
- •5. Healthy
- •6. Non-pregnant and non-lactating, and have a negative urine pregnancy test result if subject is female
- •7. Use reliable contraception, i.e. two methods simultaneously if subject is female and of childbearing potential
排除标准
- •1. Subjects with any relevant clinical abnormality
- •2. Subjects with a tendency to loose stools and/or subjects with the history of a relevant surgical abdominal intervention
- •3. Subjects with any cardiac arrhythmia, subjects with acute infections within the last two weeks
- •4. Subjects with a history of any allergic disease with clinical signs
- •5. Subjects with suspicion of hypersensitivity to the investigational medication
- •6. Subjects with a history of severe skin reactions
- •7. Subjects receiving any medication within 2 weeks prior to study start or during the study
- •8. Subjects who have taken a drug with a long half-life (greater than 24 hours) within four weeks before the first trial day
- •9. Subjects who received chronic drug treatment (greater than 3 days) within eight weeks before the first trial day
- •10. Subjects who donated blood within the last 4 weeks before the start of the present study
- •11. Actual smokers defined as subjects who smoked any cigarette during the last three months
- •12. Subjects who are known or suspected to be (social) drug dependent
- •13. Subjects with a history of alcohol or recreational drug addiction
- •14. Subjects with positive drug screening tests
- •15. Subjects who are not willing or able to abstain from alcohol, methylxanthine-containing beverages and foods, and grapefruit flesh/juice from 1 week prior to the study until the safety follow-up examination
- •16. Anticipated problems of successfully placing an indwelling venous catheter at both forearms
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