To investigate the pharmacokinetics of hospital pharmacy compounded CDCA capsules, compared to the commercial alternative.
ID
Source
Brief title
Condition
- Inborn errors of metabolism
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetic parameters of hospital pharmacy compounded CDCA capsules,
compared to those of the commercial alternative.
Secondary outcome
Impact on other bile acids.
Background summary
Amsterdam UMC is treating its own patients with hospital pharmacy compounded
CDCA capsules.
Study objective
To investigate the pharmacokinetics of hospital pharmacy compounded CDCA
capsules, compared to the commercial alternative.
Study design
Single center, open label, cross-over study.
Intervention
CDCA 250 mg capsule.
Study burden and risks
Burden: 2 visits, 2 capsule-intakes, 2 times blood withdrawal
Estimated risk: minimal
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- 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
Exclusion criteria
- Inability to give informed consent
- Hypersensitivity to one of the components in either product
- moking 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2021-003823-14-NL |
CCMO | NL78477.018.21 |
OMON | NL-OMON23443 |