Urinary excretion levels of MMX-mesalazine in healthy volunteers

Urinary excretion levels of MMX-mesalazine in healthy volunteers: a non-randomised study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15765858

Enrollment

Registered

2015-02-24

Start date

2013-07-24

Completion date

Unknown

Last updated

2015-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary excretion MMX-mesalazine, pharmacokinetics. Now studied in healthy volunteers. To be used in inflammatory bowel disease (IBD) patients in the future. Digestive System

Interventions

All 25 healthy adult volunteers used MMX-mesalazine ( 2400 mg once daily (OD) (days 1-4), followed by 1200 mg twice daily (BID) (days 8-11), separated by a drug-free interval of 3 days (days 5-7). D

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. > 18 years 2. No comorbidity 3. No relevant co-medication especially NSAIDs or aspirin 4. Not pregnant

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Relevant co-morbidity 3. Relevant co-medication

Design outcomes

Primary

Measure	Time frame
1. Feasibility, sensitivity, and reproducibility of high-performance liquid chromatography (HPLC) to measure urinary (NAc-) 5-ASA excretion in healthy volunteers taking MMX mesalazine 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

Measure	Time frame
Adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026