EUCTR2021-003823-14-NL进行中（未招募）1 期
Pharmacokinetic cross-over study of compounded chenodeoxycholic acid. - CDCA-PK
Amsterdam UMC0 个研究点目标入组 12 人开始时间: 2021年11月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
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
- •-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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