TABLE 3

Pharmacokinetic parameters for midazolam and ketoconazole after 0.2 mg/kg i.v. administration of midazolam with a concomitant oral dose of vehicle or ketoconazole (5 or 100 mg/kg) in cynomolgus monkeys

Each value represents the mean ± S.D. of four monkeys.

CmaxTmaxt1/2CLtotVdssAUCinf
ng/mlhhml/(h · kg)ml/kgh · ng/ml
Midazolam
    + Vehicle3.1 ± 0.4651 ± 932865 ± 174312 ± 47
    + 5 mg/kg ketoconazole3.2 ± 0.3751 ± 393416 ± 370267 ± 13
    + 10 mg/kg ketoconazole4.1 ± 0.6*629 ± 553706 ± 838320 ± 26
Ketoconazole
    5 mg/kg231 ± 2242.5 ± 1.05.9 ± 2.6660 ± 418
    100 mg/kg2891 ± 21327.0 ± 2.05.5 ± 4.232,403 ± 25,428
  • * p < 0.05, compared with the vehicle.