A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer

Table 2 Serum testosterone concentrations (rounded-up values) and equivalence analysis

	LS mean (SE) of serum testosterone concentration, ng/dL^a		AAT(II) vs. OAA GMR (90% CI)	AAT(II) vs. OAA LS mean difference (95% CI)
	AAT(II) (N = 34)	OAA (N = 34)	AAT(II) vs. OAA GMR (90% CI)	AAT(II) vs. OAA LS mean difference (95% CI)
Day 9 and/or Day 10	1.075 (0.034)	1.000 (0.034)	1.053 (0.998, 1.110)	0.075 (− 0.021, 0.171)
Day 28	1.020 (0.014)	1.000 (0.013)	1.015 (0.991, 1.041)	0.020 (− 0.018, 0.058)
Day 56	1.028 (0.020)	1.000 (0.019)	1.020 (0.987, 1.054)	0.028 (− 0.027, 0.083)
Day 84	1.064 (0.037)	1.000 (0.037)	1.042 (0.988, 1.100)	0.064 (− 0.041, 0.169)

AAT(II) Abiraterone acetate tablets (II), OAA Originator abiraterone acetate, LS Least squares, SE Standard error, CI Confidence interval, GMR Geometric mean ratio
^aValues < 1 ng/dL were rounded up to 1 ng/dL

ISSN: 1741-7015