2 period study comparing a new drug called Chronocort® against Cortef®
Research type
Research Study
Full title
A single centre, open-label, randomised, single dose, two-period, crossover relative bioavailability study of Chronocort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male subjects.
IRAS ID
236255
Contact name
Annelize Koch
Contact email
Sponsor organisation
Diurnal Ltd
Eudract number
2016-001390-32
Duration of Study in the UK
0 years, 8 months, 14 days
Research summary
This study will be looking at new preparation of a marketed drug (hydrocortisone) called Chronocort® (Test drug).
Chronocort® is a newly developed formulation of hydrocortisone and is designed to help people suffering from adrenal insufficiency. In people who suffer from adrenal insufficiency the adrenal glands, located above the kidneys, are not producing enough hormones, in particular, cortisol (often called the stress hormone) and therefore they need to take hydrocortisone to help them.
In this study, we will compare Chronocort® against a drug called Cortef® (Reference drug). Cortef® is a marketed version of hydrocortisone that has been available for many years, since the 1950s. In order to compare Chronocort® and Cortef® blood samples will be taken at pre-determined time points to measure the levels of cortisol in blood. Since subjects are healthy they will produce cortisol (stress hormone) naturally, however for this study we need to stop this production temporarily with a drug called dexamethasone. Dexamethasone suppresses levels of cortisol, therefore taking dexamethasone throughout the study will allow us to learn more about the drugs and to see if the drugs have similar characteristics.
This study will be conducted in 24 healthy male subjects.The study will comprise of a pre-study screen (28 days before start of the study), followed by 2 treatment periods (1 and 2) and a post-study follow up. Eligible subjects will receive a single-dose of each IMP (test of reference) over two treatment periods (1/period as determined by the randomisation schedule).
REC name
Wales REC 1
REC reference
17/WA/0333
Date of REC Opinion
8 Nov 2017
REC opinion
Favourable Opinion