Healthy volunteers
Conditions
Interventions
Product Name: Claversal
Pharmaceutical Form: Tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Produc
Sponsors
KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers aged between 18 and 35 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 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Allergic to PPI or mesalazine Acute/chronic gastro-intestinal disease diabetic, cardiovascular disease, pulmonitis, or renal disease (possible) pregnancy and when breastfeeding medicine (contraception excluded) smoker HIV, HBV or HVC contamination lactose intolerant Allergic to soy or peanuts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the disposition and bioavailability of mesalazine at the level of the colon and blood;Secondary Objective: Not applicable;Primary end point(s): Insight into the disposition of mesalazine after analysis of biopsies, plasma, and colonic fluids of healthy volunteers;Timepoint(s) of evaluation of this end point: 11/2021 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secundary endpoints;Timepoint(s) of evaluation of this end point: no timepoint | — |
Countries
Belgium
Contacts
Public ContactDrug Delivery & Disposition
KU Leuven
Outcome results
None listed