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 and patients with
mildly active UC. Overall, nine [9] subjects per prototype coating (a total of 18) will be
evaluated. Four [4] healthy subjects and five [5] patients will be administered one [1]
radio-labelled tablet of either formulation D or formulation E, respectively.
Amendment: Overall, nine [9] subjects/patients will be evaluated. Four [4] healthy subjects
and five [5] patients will be administered one [1] radio-labelled tablet of this new third
improved formulation H.
In order to keep the number of patients low, recruitment of patients will be stopped when
obtaining at least 3 patients with evaluable scintigraphic images. Healthy volunteers will
then be recruited to achieve a full set of participants (n=9 per Arm).