The influence of the body on the fate of mesalazine in healthy volunteers
Phase 1
- Conditions
- Healthy volunteersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2019-003728-19-BE
- Lead Sponsor
- KU Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method