This is a single centre, open-label, randomised, single dose, three-period, crossover study to evaluate the bioavailability of Infacort® administered as 'sprinkles' with soft food and yoghurt compared with direct administration to the back of the tongue in dexamethasone-suppressed healthy adult male subjects. The study will comprise of a pre-study screen, followed by 3 treatment periods and a post-study follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Immediate-release multiparticulate formulation of hydrocortisone.
Simbec Research Ltd.
Merthyr Tydfil, United Kingdom
Area under the curve (AUC) (0-t) of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue
The pharmacokinetic parameter AUC0-inf of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Time frame: 12 hours post-IMP administration
Area under the curve (AUC) (0-infinity) of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue
The pharmacokinetic parameter AUC0-inf of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Time frame: 12 hours post-IMP administration
Cmax of Infacort administered with yoghurt and soft food compared to dry granules administered to the back of the tongue.
The pharmacokinetic parameter Cmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Time frame: Up to 12 hours post-IMP adminstration
Tmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Tmax of Infacort® administered as sprinkles with yoghurt and soft food compared to Infacort® administered as dry granules to the back of the tongue.
Time frame: Up to 12 hours post-IMP administration
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