The behaviour of the drug tacrolimus in the stomach of healthy volunteers
Phase 1
- Conditions
- Healthy human volunteers , investigation of the drug's supersaturation behaviour in the stomachTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2016-002519-17-BE
- Lead Sponsor
- KU Leuven - Drug Delivery and Disposition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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 5
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: Study the gastric behaviour of tacrolimus in healthy volunteers in fasted and fed state and when co-ingested with other beverages than water.;Secondary Objective: Non 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