An Investigational Study of Hydrocortisone

Exclusion Criteria

• •A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
• •Receipt of regular medication within 14 days prior to Day 1 of Study Period 1 (including high dose vitamins, dietary supplements or herbal remedies).
• •Receipt of any vaccination within 14 days prior to Day 1 of Study Period 1.
• •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).
• •Participation 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 is 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 have consumed more than 2 units of alcohol per day within seven (7) days prior to Day 1 of Study Period 1or have consumed any alcohol within the 48 hour period prior to Day 1 of Study Period 1.
• •Donation of 450ml or more of blood within the previous 3 months.
• •Subjects who smoke (or ex-smokers who have smoked within 6 months prior to Day 1 of Study Period 1).
• •Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).