rinary excretion levels of MMX-mesalazine in healthy volunteers
Completed
- Conditions
- rinary excretion MMX-mesalazine, pharmacokinetics. Now studied in healthy volunteers. To be used in inflammatory bowel disease (IBD) patients in the future.Digestive System
- Registration Number
- ISRCTN15765858
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
1. > 18 years
2. No comorbidity
3. No relevant co-medication especially NSAIDs or aspirin
4. Not pregnant
Exclusion Criteria
1. Pregnancy
2. Relevant co-morbidity
3. Relevant co-medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Feasibility, sensitivity, and reproducibility of high-performance liquid chromatography (HPLC) to measure urinary (NAc-) 5-ASA excretion in healthy volunteers taking MMX mesalazine<br>2. Adherence: The cut-off-level for adherence was defined as the total (Nac)5-ASA urinary excretion level, as measured in at least 95% of the subjects, taking 2400 mg MMX-mesalazine OD or BID
- Secondary Outcome Measures
Name Time Method Adverse events