Conditions: Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: yes

Brief summary:
This was a single centre, open-label, randomised, 5-way crossover study.

Detailed description:
This was a single centre, open-label, randomised, 5-way crossover study design to compare the PK of Infacort® versus immediate-release hydrocortisone tablets and to evaluate the dose proportionality of 0.5 mg, 2 mg, 5 mg and 10 mg Infacort®. The study was conducted in 1 cohort of 16 healthy male subjects and comprised a Screening Visit, 5 treatment periods (Treatment Periods 1 to 5) and a Post-study Visit.

Arms:
arm 1: Multi-particulate granules from 1 (0.5 mg) capsule arm 2: Multi-particulate granules from 1 (2 mg) capsule arm 3: Multi-particulate granules from 1 (5 mg) capsule arm 4: Multi-particulate granules from 1 (10 mg) capsule arm 5: 1 (10 mg) tablet

Interventions: intervention 1: Infacort intervention 2: Hydrocortisone
Intervention descriptions: intervention 1: Multi-particulate granules intervention 2: Tablet

Protocol document: