Study on pharmacy prepared CDCA capsules
- Conditions
- 10014699<p>Cerebrotendinous Xanthomatosis</p>
- Registration Number
- NL-OMON23443
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetic profile of compounded CDCA capsules</p><br>
- Secondary Outcome Measures
Name Time Method <p>Effect on bile acid profile</p><br>