Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone

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

Inclusion Criteria: * Healthy male volunteers between 18 and 60 years of age, inclusive (at Screening Visit). * Subjects with a Body Mass Index (BMI) of 21-28. * Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days prior to the first dose of investigational medicinal product (IMP). * Subjects with a negative urinary drugs of abuse screen determined within 14 days prior to the first dose of IMP. A positive alcohol test may have been repeated at the discretion of the Investigator. * Subjects with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results. * Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to the first dose of IMP. * Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements. * Subjects (unless anatomically sterile or where abstaining from sexual intercourse was in-line with the preferred and usual lifestyle of the subject) and sexual partners used effective contraception methods during the trial and for 3 months after the last dose of IMP, for example; oral contraceptive + condom, intra-uterine device (IUD) + condom or diaphragm with spermicide + condom. * Subjects were available to complete the study. * Subjects satisfied a medical examiner about their fitness to participate in the study. * Subjects provided written informed consent to participate in the study. Exclusion Criteria: * A clinically significant history of gastrointestinal disorder likely to influence drug absorption. * Receipt of regular medication within 14 days prior to the first dose of IMP (including high dose vitamins, dietary supplements or herbal remedies). * Receipt of any vaccination within 14 days prior to the first dose of IMP. * Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. * Presence of clinically significant infections (systemic fungal and viral infections, acute bacterial infections). * Current or previous history of tuberculosis. * A clinically significant history of previous allergy / sensitivity to hydrocortisone and/or dexamethasone. * A clinically significant history or family history of psychiatric disorders/illnesses. * A clinically significant history of drug or alcohol abuse. * Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function). * Participated in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. The washout period between trials was defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study). * Subjects who had consumed more than 2 units of alcohol per day within 7 days prior to the first dose of IMP or had consumed any alcohol within the 48 hr period prior to the first dose of IMP. * Donation of 450 mL or more of blood within the previous 3 months. * Subjects who smoked (or ex-smokers who had smoked within 6 months prior to first dose of IMP). * Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).