Cortiment® MMX Pharmacokinetic Study

Summary

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.

Timeline

Start

2019-09-16

Primary completion

2019-09-25

Completion

2019-09-25

Drugs

Indications

No indication recorded.