This was an open label, randomised, single dose study, comprising Part A (undertaken in two separate three-period crossover cohorts denoted as A1 and A2) and Part B (undertaken in one four-period crossover cohort), to evaluate the PK of Chronocort® in healthy male volunteers. The washout interval in both Part A and Part B was 1-week in between each treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Modified formulation of hydrocortisone
To compare the Tmax of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period. Parts A1 & A2 only
Time at maximum concentration in serum
Time frame: 18 hours
To compare the Cmax of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period. Parts A1 & A2 only
Maximum serum concentration
Time frame: 18 hours
To compare the AUC0-t of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period.
Area under the plasma concentration-time curve
Time frame: 18 hours
To compare the AUC0-∞ of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period.
Area under the plasma concentration-time curve from zero (0) hours to infinity (∞)
Time frame: 18 hours
To compare the CL of six formulations of Chronocort® (30 mg, dosed at night) over an 18 hour period.
Drug clearance (CL) is defined as the volume of plasma in the vascular compartment cleared of drug per unit time
Time frame: 18 hours
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