Table 3 Summary of pharmacokinetic similarity analysis in Study 1 and Study 2

Parameters

ANOVA

ANCOVA^a

ANOVA

ANCOVA^a

C_max

1.07 (0.99, 1.16)

1.06 (0.99, 1.13)

1.05 (1.00, 1.11)

1.05 (1.01, 1.10)

AUC_0-t

1.17 (1.05, 1.30)^b

1.15 (1.04, 1.28) ^b

1.11 (1.01, 1.23)

1.12 (1.01, 1.23)

AUC_0-∞

1.16 (1.03, 1.31) ^b

1.16 (1.04, 1.29) ^b

1.11 (0.99, 1.24)

1.12 (1.00, 1.25)^b

AUC_0–360

1.10 (1.01, 1.19)

1.08 (1.01, 1.16)

1.04 (0.98, 1.10)

1.04 (0.99, 1.10)

T_1/2

1.14 (0.97, 1.35)^b

1.14 (0.97, 1.34)^b

1.02 (0.86, 1.22)

1.02 (0.85, 1.22)