An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone

Inclusion Criteria

• •Healthy male volunteers between 18 and 60 years of age, inclusive (at screening).
• •Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))2.
• •Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days of the start of the study. The parameters measured included those shown in Appendix 3 of the Study Protocol.
• •Subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study.
• •Subjects with negative HIV and Hepatitis B and C results.
• •Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.
• •Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
• •Subjects and sexual partners must have used effective contraception methods during the trial and for 3 months after the last dose, for example:
• •* Oral contraceptive + condom
• •* Intra-uterine device (IUD) + condom
• •* Diaphragm with spermacide + condom
• •Subjects must have been available to complete the study.
• •Subjects must have satisfied a medical examiner about their fitness to participate in the study.
• •Subjects must have provided written informed consent to participate in the study.