ISRCTN70153100已完成不适用
A phase I study to assess the effects of repeated oral doses of Sokatin® (WS® 1261) for 2 weeks on emotional memory and set shifting in healthy volunteers
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 48 人开始时间: 2010年4月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
- Male
入选标准
- •1. Aged 20 - 30 years
- •3. Caucasian
- •4. Informed consent in accordance with the legal requirements
- •5. Healthy
- •6. Normal body weight
排除标准
- •1. Subjects with conspicuous findings in medical history and pre-study examination
- •2. Blood donation of approximately 500 ml within 3 months prior to the study start
- •3. A history of relevant diseases of vital organs, of the central nervous system or other organs
- •4. Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
- •5. Febrile illness within 1 week before the start of the study
- •6. Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
- •7. Regular daily consumption of more than 10 cigarettes
- •8. Regular daily consumption of more than half a litre of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
- •9. Regular use of therapeutic or recreational drugs
- •10. Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
- •11. Relevant deviation from the normal range in the clinical examination
- •12. Relevant deviation from the normal range in clinical chemistry, haematology or urinalysis
- •13. Resting heart rate in the awake subject below 45 beats per minute (BPM) or above 90 BPM
- •14. Systolic blood pressure below 100 mmHg or above 140 mmHg
- •15. Diastolic blood pressure above 85 mmHg
- •16. Subjects testing positive in the drug screening
- •17. Excluded therapies (e.g., physiotherapy, acupuncture, etc)
- •18. Gastrointestinal disorders with uncertain absorption of orally administered drugs
- •19. Volunteer in custody or submitted to an institution due to a judicial order
- •20. Contraindications for magnetic resonance imaging: metallic implants (including non-removable body piercing), large tattoos, medical or biostimulation implants such as pacemaker, claustrophobia, allergy to the contrast agent
研究者
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