Table 2.

Bioequivalence parameters of PL-ASA and IR-ASA in healthy volunteers

	Ratio (%)a	90% CIb	P valuec
Salicylic acid 325-mg dose (n = 13)
AUC0−t (μg × min/mL) (n = 13)	97	89–104	0.43
AUC0-∞ (µg × min/mL) (n = 13)	98	91–106	0.62
Cmax (μg /mL) (n = 13)	104	92–117	0.59
Salicylic acid 650-mg dose
AUC0−t (μg × min/mL) (n = 14)	98	93–103	0.44
AUC0-∞ (µg × min/mL) (n = 14)	99	95–103	0.66
Cmax (μg/mL) (n = 14)	106	97–115	0.25
Acetylsalicylic acid 325-mg dose
AUC0−t (μg × min/mL) (n = 13)	94	83–107	0.41
AUC0-∞ (µg × min/mL) (n = 7)	86	72–102	0.13
Cmax (μg/mL) (n = 13)	114	81–159	0.51
Acetylsalicylic acid 650-mg dose
AUC0−t (μg × min/mL) (n = 14)	92	86–99	0.06
AUC0-∞ (µg × min/mL) (n = 11)	91	86–98	0.03
Cmax (μg/mL) (n = 14)	105	76–145	0.78

Only subjects who received both treatments and whose appropriate dosing was verified are included

AUC_0−t area-under-the-curve, AUC_0–∞ AUC_0−t extrapolated to infinity, CI confidence interval, C_max maximum plasma concentration, IR-ASA immediate release aspirin, μg micrograms, min minutes, mL milliliters, n number, PL-ASA pharmaceutical lipid–aspirin complex, t_max time of peak drug concentration, λ_z terminal elimination rate constant, t_½ first-order elimination half-life

^aRatio = 100 × Geometric mean (PL-ASA)/geometric mean (IR- ASA)

^b90% Confidence interval on the ratio of PL-ASA to IR-ASA

^cANOVA p-value for the difference in the treatment estimates