Pain Research and Management

Research Article

Pharmacokinetic Characterisation and Comparison of Bioavailability of Intranasal Fentanyl, Transmucosal, and Intravenous Administration through a Three-Way Crossover Study in 24 Healthy Volunteers

Table 5

Pharmacokinetic parameters for single administration of TRANSMUCOSAL.


TRANSMUCOSAL (oral transmucosal fentanyl citrate, 1 lozenge, 200 μg)—one lozenge (administration over 15 minutes)
	AUC_0-tlast	AUC_0-∞	AUC_expol%	C_max	C_last	t_max	t_1/2	t_last	λ_z	MRT

N	24	21	21	24	24	24	21	24	21	21
Unit	h pg/ml	h pg/ml	%	pg/ml	pg/ml	h	h	h	1/h	h
Arith. Mean						1.20	12.09	11.76	0.10910	3.74
SD						0.763	16.190	1.226	0.09975	0.567
Min	434	457	4.91	164	11	0.42	1.35	6.00	0.00899	1.81
Median	1102	1452	26.50	326	37	1.04	7.86	12.00	0.08824	3.83
Max	1925	7017	80.98	535	77	2.52	77.09	12.05	0.51173	4.53
Geom. Mean	1106	1605	23.89	310	34
CV% geom. Mean	32.86	61.49	64.02	29.58	47.21

AUC_0-tlast: area under the plasma concentration versus time curve from dosing time to the last measurement time point with concentration value above the lower limit of quantitation; AUC_0-∞: area under the plasma concentration versus time curve from dosing time to the infinite; AUC_expol%: fraction of the total AUC due to extrapolated AUC; C_max: maximum concentration in plasma; C_last: concentration at the last time quantifiable point; t_max: time to reach maximum drug concentration; t_1/2: terminal half-life; t_last: last quantifiable time point; λ_z: apparent terminal elimination rate constant; MRT: mean residence time; SD: standard deviation; CV%: coefficient of variation.