Budesonide is a well-known and well-characterised locally acting glucocorticosteroid with
comparable efficacy to that of conventional glucocorticosteroids, but with fewer systemic
side effects due to its low bioavailability following oral administration.
There are no benefits for subjects participating in this pharmacokinetic (PK) profile and
safety study. This is an open-label study to investigate the PK profile and safety of single
oral dose of budesonide prolonged release tablets (9 mg, Cortiment® MMX [multi-matrix
system]) in healthy subjects in Indian population.
Two study visits are planned: One out-patient visit (screening) and one residential session
consisting of three consecutive nights (admission to the clinical investigation unit at least
12 hours before dosing and discharge approximately 60 hours after dosing). End-of-study
assessments will be performed before discharge from the clinical investigation unit in the
single dosing period. Subjects should be in the fasted state for at least 10 hours pre-dose.
Number of subjects planned in total in the study are 24 men and women, with a minimum
requirement of 7 women. The safety assessments comprise of adverse events (AEs), vital signs,
electrocardiogram (ECG) and clinical laboratory variables. Adverse events will be collected
throughout the study.