Comparison of a novel fast-dissolving acetaminophen tablet formulation (FD-APAP) and standard acetaminophen tablets using gamma scintigraphy and pharmacokinetic studies

Figures & data

Figure 1.  Mean in vivo disintegration time for fast-dissolving acetaminophen tablet formulation (FD-APAP) versus standard acetaminophen.

Figure 2.  Representative scintigraphic images in one subject showing gastric emptying at 5 and 20 min after both study treatments.

Table 1.  Bioequivalence and nonparametric pharmacokinetic variables.

Bioequivalence variables	FD-APAP^a	Standard acetaminophen^a	Point estimate^b	90% CI for point estimate
AUC0–t (μg·h/mL)	47.60	46.83	1.02	0.98, 1.05
AUC0–inf (μg·h/mL)	51.45	50.61	1.02	0.98, 1.05
Cmax (μg/mL)	18.96	16.86	1.12	0.99, 1.28
Rate of absorption variables	FD-APAP^c	Standard acetaminophen^c	Median difference^d	95% CI for median difference (P-value)
Tmax (h)	0.50	0.67	–0.2497	–0.459,−0.084 (0.0061)
AUC0–30 min (μg·h/mL)	4.51	2.74	1.5200	0.175, 2.905 (0.0318)

^aLS mean from ANOVA of logged data. Back-transformed values are presented (antilog).

^bTreatment difference from ANOVA of log-transformed data. Back-transformed values are presented (antilog) This represents the treatment mean as a ratio of the reference mean.

^cMedian value.

^dHodges–Lehmann estimator for median treatment difference from nonparametric analysis.

Figure 3.  Mean plasma acetaminophen concentration–time profiles.