Supersaturation and precipitation of diclofenac in the stomach of healthy human volunteers
Phase 1
- Conditions
- Healthy human volunteers (administration of a Non-Steroidal Anti-Inflammatory Drug)Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2013-004636-29-BE
- Lead Sponsor
- KU Leuven - Drug Delivery & Disposition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Healthy volunteers
- Age between 18 and 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
- disease
- acute/chronic GI condition
- use of medication
- pregnancy
- frequent exposure to X-rays during the past year
- HIV / HBV / HCV infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This study aims to investigate principles of gastric supersaturation and precipitation of a weakly acidic drug in healthy human volunteers. Specifically the influence of nutritional state and coadministration of proton-pump inhibitors will be investigated.;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable