Table 1.
Summary of pharmacokinetic parameters of fentanyl in serum and performance of the novel matrix and reservoir transdermal delivery system of fentanyl (100 µg h−1) in healthy subjects (n = 24)
| Descriptive statistics | |||
|---|---|---|---|
| Parameters | Novel matrix delivery system | Reservoir delivery system | anovaRatio of LSM(90% CI) |
| Pharmacokinetics | |||
| AUC0–t (pg h ml−1)* | 142 682 (25.0%) | 135 877 (22.1%) | 105.5 (99.4, 112.0) |
| AUCinf (pg h ml−1)* | 145 126 (25.2%) | 138 822 (22.6%) | 105.3 (99.3, 111.6) |
| Cmax (pg ml−1)* | 2 352 (34.8%) | 2 117 (27.2%) | 111.4 (100.4, 123.6) |
| Tmax (h)† | 31.5 (35.7%) | 33.1 (40.3%) | 95.2 (84.0, 106.4) |
| T1/2 (h)† | 20.3 (22.4%) | 20.9 (27.3%) | 97.7 (89.8, 105.5) |
| Performance | |||
| Residual amount (mg)* | 2.08 (49.6%) | 1.69 (36.9%) | 123.9 (108.8, 141.1) |
| Adherence (%)† | 63.5 (17.5%) | 63.7 (21.3%) | −0.400 (−4.90, 4.10)‡ |
| Irritation score† | 0.895 (99.3%) | 0.678 (72.5%) | 0.178 (−0.060, 0.416)‡ |
AUC0–t, Area under the concentration–time curve from time 0 to the last measurable concentration; AUCinf, area under the concentration–time curve extrapolated to infinity; Cmax, maximum plasma concentration; Tmax, time of maximum measured plasma concentration; T1/2, terminal elimination half-life.
*
Geometric mean (geometric CV%).
†
Arithmetic mean (arithmetic CV%).
‡
Difference in least-squares mean (LSM) (95% CI).