Table 1.

Statistical analysis of log-normalized ratio of PL-ASA to EC-ASA for acetylsalicylic acid PK parameters. – PK population (N = 36)

Parameter	PL-ASA	EC-ASA	Ratio (%)	95% CI	p-value
AUC0-t (h*ng/mL)a	601 (41.1)	416 (53.7)	144	117–178	0.0013
Cmax (ng/mL)a	720 (33.7)	368 (80.3)	196	148–259	< 0.0001
Tmax (h)b	1.01 (0.47, 3.03)	4.00 (1.50, 6.63)			< 0.0001

The AUC_0-t and C_max analyses were performed on log-transformed parameters using a linear mixed-effects ANOVA model with treatment, period, and sequence as fixed effects and subject as a random effect

AUC_0-t area under curve from time zero to last measurable concentration, C_max maximum concentration, CI confidence interval, h hour, PK pharmacokinetic

^aGeometric least square mean (coefficient of variation, %)

^bMedian (range)