Table 3.

Study 102 summary of plasma pharmacokinetic parameters (pharmacokinetic population)

Pharmacokinetic parameter	Summary statistics	Treatment (mg)a
		AAFP 125	AAFP 500	AAFP 625	OAA 1000
	N	33	34	34	33
AUC0–∞ (ng·h/mL)	Mean	112.12	438.02	473.31	453.18
	SD	65.94	249.43	247.19	219.07
	CV%	58.81	56.94	52.23	48.34
	Geometric mean	93.86	372.67	418.21	408.60
AUC0–t (ng·h/mL)	Mean	102.55	416.23	450.19	415.91
	SD	63.27	245.73	241.85	210.67
	CV%	61.70	59.04	53.72	50.65
	Geometric mean	84.75	350.02	394.76	372.51
C max (ng/mL)	Mean	28.22	84.16	100.76	83.40
	SD	16.46	44.05	63.75	57.40
	CV%	58.34	52.34	63.27	68.83
	Geometric mean	23.98	73.45	84.07	70.44
t max (h)	Median	1.5	1.5	1.5	2
	Minimum	0.5	0.5	0.5	0.5
	Maximum	4	6	4	8
t ½ (h)	Mean	7.20	14.12	14.54	20.64
	SD	3.47	6.44	5.54	9.03
	CV%	48.28	45.61	38.07	43.75
	Geometric mean	6.27	12.59	13.63	18.77
K e (/h)	Mean	0.13	0.06	0.05	0.04
	SD	0.09	0.05	0.02	0.02
	CV%	65.70	71.26	36.10	46.69
	Geometric mean	0.11	0.06	0.05	0.04

AAFP abiraterone acetate fine particle, AUC _0–∞ area under the plasma concentration–time curve from time zero to infinity, AUC _0–t area under the plasma concentration–time curve from time zero to the time of the last quantifiable concentration, C _max maximum plasma concentration, CV% coefficient of variation expressed as percent, K _e apparent elimination rate constant, N number of subjects included in the pharmacokinetic population for each treatment, OAA originator abiraterone acetate, SD standard deviation, t _½ elimination half-life, t _max time to maximum plasma concentration

^aAAFP 125 mg (1 × 125 mg), 500 mg (4 × 125 mg), 625 mg (5 × 125 mg), and OAA 1000 mg (4 × 250 mg) under fasted conditions