Pharmacology of pharmacy prepared chenodeoxycholic acid.
- Conditions
- CTXCTTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2021-003823-14-NL
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 12
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method