Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)

"Drug: ITF2357 Givinostat 10mg/mL Dose: 10mg/mL; Dosage form: oral suspension~On days 1 and 13 givinostat was administered in the morning, following an overnight fasting of at least 8 hours and subjects remained fasted until at least 4 hours post-dose. Moreover the subjects were in a semi-recumbent position and remained semi-recumbent until at least 4 hours post-dose.No fluids were allowed from 1 hour before dosing until 2 hours post-dose. Water was provided ad libitum at all other times.~From Day 5 to Day 12, subjects received givinostat 50 mg as oral suspension, twice a day, in the morning and in the evening."