Gastrointestinal behaviour of mesalazine in healthy volunteers
Phase 1
- Conditions
- Healthy volunteersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2019-001009-26-BE
- Lead Sponsor
- KU Leuven - Drug Delivery and Disposition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
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
- 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
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