Safety and pharmacodynamic dose response of short-term prednisone in healthy adult subjects: a dose ranging, randomized, placebo-controlled, crossover study

Table 3 Number of subjects with abnormal and normal responses to ACTH stimulation tests performed every 2 weeks

Treatment sequence	Subjects, n	Period			Subjects with abnormal response to ACTH stimulation, n
		1	2	3	Test 1	Test 2^a	Test 3^b
					(N = 37)	(N = 18)	(N = 2)
A	5	Placebo	2.5 mg	10 mg	3	0	0
B	5	2.5 mg	5 mg	20 mg	5	0	0
C	5	5 mg	10 mg	40 mg	4	1	1^c
D	5	10 mg	20 mg	60 mg	5	1	0
E	6^d	20 mg	40 mg	Placebo	0	0	0
F	5	40 mg	60 mg	2.5 mg	0	0	0
G	6^d	60 mg	Placebo	5 mg	1	0	0
Total	37				18	2	1

Doses shown correspond to the daily prednisone dose administered for 7 days in each treatment period
ACTH adrenocorticotropic hormone
^aSubjects who failed Test 1 were re-tested 2 weeks later
^bSubjects who failed Test 2 were re-tested 2 weeks later
^cReturned to normal on Study Day 138
^dOne subject in sequence E and one in sequence G discontinued the study during Period 2 and were replaced following approval by the study statistician, therefore n = 6 in these groups for this analysis

ISSN: 1471-2474