TABLE 4

Pharmacokinetics of nalmefene in males and females following intranasal and intramuscular administration

Parameter (U)a3 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.