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. 2022 Jan 20;61(4):465–479. doi: 10.1007/s40262-021-01090-2

Table 2.

PK bioequivalence ratios of PK parameters for salicylic acid concentrations of PL-ASA and (plain) IR-ASA at 325 and 650 mg doses

Ratio (%)a 90% CIb p valuec
Salicylic acid parameters, 325 mg dose (n = 13)
 Cmax, ng/mL 104 92–117 0.59
 AUC0-t, ng×min/mL 97 89–104 0.43
 AUC0-, ng×min/mL 98 91–106 0.62
Salicylic acid parameters, 650 mg dose (n = 14)
 Cmax, ng/mL 106 97–115 0.25
 AUC0-t, ng×min/mL 98 93–103 0.44
 AUC0-, ng×min/mL 99 95–103 0.65

Source: Angiolillo et al. [48]

AUC area under the concentration-time curve, AUC0-t AUC from time 0 to the time t of the last measurable concentration, AUC0-∞ AUC from time zero to infinity, Cmax peak plasma concentration, CI confidence interval, IR-ASA immediate-release aspirin, PK pharmacokinetic, PL-ASA phospholipid-aspirin complex

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