Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone
Condition: Healthy Subjects
Intervention: Infacort; Hydrocortisone
Intervention description: Multi-particulate granules; Tablet
Intervention MeSH terms: Hydrocortisone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

Eligibility criteria:

        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).