NL-OMON23443已完成4 期
Pharmacokinetic cross-over study of compounded chenodeoxycholic acid
Amsterdam UMC0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
A
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Be 18 years of age or older - Be a male - Have a BMI between 18,5 and 30 kg/m2 - Able and willing to swallow the capsules - Able to undergo blood sampling for PK analysis - Able and willing to give written informed consent - Willing to follow the dietary restrictions - Able to complete the study
排除标准
- •- Inability to give informed consent - Hypersensitivity to one of the components in either product - Smoking or use of other tobacco products - History of alcohol or drug abuse - Use of co-medication (as described in chapter 5.2) - Gastrointestinal disease that may impact the absorption - Metabolic or endocrine disease - Gallbladder disease and/or removal - Liver disease - Participation in another clinical trial during or in the 3 months prior to the study
研究者
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