ISRCTN64029954已完成不适用
A phase I study to assess the safety and tolerability of repeated oral doses of 1200 mg and 2400 mg Dulamin once daily for 2 weeks in healthy volunteers as well as to evaluate the relative bioavailability of film-coated tablets containing 1200 mg Dulamin and to evaluate effects of food on its pharmacokinetics
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 36 人开始时间: 2013年2月18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
- 36
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. Age 18-45 years
- •2. Caucasian
- •3. Informed consent
- •3. Healthy men and women
- •4. Body mass index between 18 and 29 kg/m2
排除标准
- •1. More than moderate smoker
- •2. Demonstrating excess in xanthine consumption
- •3. More than moderate alcohol consumption
- •4. Any history of alcohol or drug abuse
- •5. Demonstrating any active physical disease, acute or chronic
- •6. History or any current evidence of clinically relevant allergies or idiosyncrasies to drugs or food
- •7. History (within the last 2 years) of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis as well as current hay fever 8. Proneness to orthostatic dysregulation, fainting, or blackouts
- •9. ECG abnormalities of clinical relevance
- •10. History (within the last 2 years) of chronic gastritis or peptic ulcers
- •11. History (within the last 2 years) of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological (especially history of epileptic seizures), endocrine, immunological, psychiatric or cardiovascular diseases, myopathies, or bleeding tendency
- •12. History (within the last 2 years) of malignancy
- •13. Pregnant or nursing women
- •14. Women of childbearing potential who are not using a highly-effective method of birth control
- •15. Laboratory values outside the reference range that are of clinical relevance
- •16. Positive test for human immunodeficiency virus (HIV) antibodies and antigens
- •17. Positive Hepatitis B-virus surface antigen (HBsAg) test
- •18. Positive Anti-hepatitis C-virus antibodies (Anti-HCV) test
- •19. Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis abuse
- •20. Ethanol consumption within 48 h before administration of IMP
- •21. Consumption of xanthine-containing food or beverages within 48 h before administration of IMP
- •22. Any gastrointestinal complaints within 7 days before first administration of IMP
- •23. Use of any medication within 4 weeks before first administration of IMP
研究者
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