TABLE 4.
Pharmacokinetics of nalmefene in males and females following intranasal and intramuscular administration
| Parameter (U)a | 3 mg IN (A) |
3 mg/0.25% DDM IN (B) |
1.5 mg IN (C) |
1.5 mg i.m. (D) |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female (N = 4) | Male (N = 10) | Female (N = 4) | Male (N = 9) | Female (N = 3) | Male (N = 8) | Female (N = 4) | Male (N = 9) | |||||||||
| Cmax (ng/ml) | 2.20 | (47.0) | 1.90 | (54.9) | 5.51 | (72.7) | 4.04 | (64.3) | 1.19 | (53.1) | 0.888 | (40.8) | 1.13 | (21.7) | 1.75 | (44.2) |
| Tmax (h) | 2.00 (2.00–2.00) | 1.52 (0.33–3.00) | 0.25 (0.25–0.25) | 0.25 (0.17–1.00) | 2.00 (1.00–2.07) | 2.00 (1.00–2.00) | 0.63 (0.25–8.00) | 0.33 (0.25–2.00) | ||||||||
| AUC0–t (ng·h/ml) | 14.6 | (57.1) | 12.0 | (74.7) | 18.4 | (84.1) | 13.9 | (69.8) | 7.38 | (75.9) | 5.03 | (51.8) | 14.0 | (33.1) | 9.38 | (45.8) |
| t1/2 (h) | 8.14b | (46.9) | 7.79 | (41.7) | 9.22 | (10.4) | 6.34 | (45.1) | 7.54 | (92.2) | 6.23c | (41.3) | 10.3 | (43.2) | 7.07d | (32.0) |
%CV, percentage coefficient of variation.
a
Geometric mean values (%CV) for all except Tmax, which is median (minimum, maximum).
b
N = 3.
c
N = 7.
d
N = 8.