Gastrointestinal behaviour of mesalazine in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001009-26-BE

Enrollment

Registered

2019-07-29

Start date

2019-09-10

Completion date

Unknown

Last updated

2023-01-30

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

Conditions

Healthy volunteers

Interventions

Trade Name: Pentasa 500 mg tabletten met verlengde afgifte Pharmaceutical Form: Modified-release tablet INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Concentration unit: mg milligram(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy volunteers age: 18 - 35 years old 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - allergy for salicylic acid derivatives - acute/chronic GI condition - diabetes, cardiovasular/pulmonary/renal diseases - use of medication (except contraception) - (possible) pregnancy - smoking - HIV / HBV / HCV infection

Design outcomes

Primary

Measure	Time frame
Main Objective: The general aim is to assess the pharmacokinetic disposition of mesalazine in the upper gastrointestinal tract of healthy volunteers. To this end, the present study persues the sampling of gastric and intestinal fluids, and blood after oral delivery of a single dose of mesalazine, in addition of Nexiam (PPI) in fasted or fed state. Hereby, four conditions will be evaluated using a cross-over design to assess differences in release of mesalazine formulations. ;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: The general aim is to assess the pharmacokinetic disposition of mesalazine in the upper gastrointestinal tract of healthy volunteers. To this end, the present study persues the sampling of gastric and intestinal fluids, and blood after oral delivery of a single dose of mesalazine, in addition of Nexiam (PPI) in fasted or fed state. Hereby, four conditions will be evaluated using a cross-over design to assess differences in release of mesalazine formulations. ;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactDrug Delivery and Disposition

KU Leuven

arno.vancamp@kuleuven.be+3216329943

Outcome results

None listed

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