This is a Phase I, open-label, single-site trial to evaluate the drug release, using scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine \[9\] subjects will be evaluated. The subjects will receive one \[1\] radio-labelled tablet after a high fat and a rich in calories breakfast.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
9
One radio-labelled tablet given to subject after a high fat and a rich in calories breakfast
Tablet release
Time frame: 3 days
Maximal Plasma Concentration (Cmax)
Time frame: 3 days
Time to reach Cmax (Tmax)
Time frame: 3 days
Area under the concentration time-curve
Time frame: 3 days
Elimination rate konstant (k)
Time frame: 3 days
Lag-time (t-lag)
Time frame: 3 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.