Table 2.
Baseline (n=9) | 3 mo (n=9) | 12 mo (n=9) | |
---|---|---|---|
Midazolam | |||
Cmax, ng/ml | 9.67 ± 6.72 | 16.09 ± 6.65a | 16.56 ± 7.55a |
Tmax, hr | 0.61 ± 0.22 | 0.28 ± 0.08a | 0.26 ± 0.08a |
Vd/F, L | 763 ± 254 | 553 ± 219a | 506 ± 260a |
Cl/F, L/hr | 91.9 ± 74.4 | 100.6 ± 58.6 | 100.1 ± 40.2 |
t1/2, hr | 8.0 ± 3.7 | 5.3 ± 3.7 | 4.5 ± 4.3 |
AUC0–last, ng·hr/ml | 20.8 ± 10.7 | 20.3 ± 10.8 | 18.3 ± 7.9 |
AUC0–∞, ng·hr/ml | 31.2 ± 15.7 | 26.8 ± 14.7 | 23.8 ± 11.2 |
1′-Hydroxymidazolam | |||
Cmax, ng/ml | 3.19 ± 2.01 | 5.97 ± 2.11a | 5.75 ± 2.00a |
Tmax, hr | 0.69 ± 0.29 | 0.35 ± 0.10a | 0.31 ± 0.05a |
t1/2, hr | 3.3 ± 1.3 | 2.5 ± 1.2 | 2.1 ± 1.3 |
AUC0–last, ng·hr/ml | 6.5 ± 3.9 | 8.1 ± 3.4 | 7.1 ± 1.9 |
AUC0–∞, ng·hr/ml | 8.5 ± 4.2 | 9.8 ± 3.9 | 8.2 ± 2.0 |
1′OH MDZ:MDZ AUC ratio | 0.35 ± 0.27 | 0.47 ± 0.28 | 0.40 ± 0.14 |
AUC = area under the concentration-time curve; Cl/F = oral clearance; Cmax = peak plasma concentration; t1/2 = serum half-life; Tmax = time to peak plasma concentration; Vd/F = apparent volume of distribution.
p<0.05 compared with baseline.