Table 1.
Control | Rifampin
|
||||
---|---|---|---|---|---|
5 mg | 10 mg | 25 mg | 75 mg | ||
IV midazolam | |||||
Cmax (ng/ml) | 62 ± 29 | 64 ± 26 | 66 ± 19 | 52 ± 23 | 82 ± 34 |
AUC0-∞ (ng •hr •ml−1) | 40.9 ± 7.6 | 34.0 ± 6.5* | 30.7 ± 4.5* | 25.2 ± 3.6* | 24.1 ± 4.5* |
AUC0-∞ ratio | 0.84± 0.13* | 0.77 ± 0.12* | 0.63 ± 0.11* | 0.60 ± 0.12* | |
(geometric mean, 90% CI) | 0.83 (0.77, 0.89) | 0.76 (0.71, 0.83) | 0.62 (0.57, 0.68) | 0.59 (0.53,0.65) | |
CLIV (ml•kg−1•min−1) | 5.9 ± 1.6 | 7.1 ± 2.1* | 7.6 ± 2.0* | 9.3 ± 1.8* | 9.8 ± 1.6* |
Elimination t1/2 (hr) | 4.0 ± 2.0 | 3.0 ± 0.8* | 2.8 ± 1.0* | 2.6 ± 1.1* | 1.9 ± 0.5* |
Vss (L/kg) | 1.4 ± 0.5 | 1.3 ± 0.4 | 1.3 ± 0.4 | 1.5 ± 0.6 | 1.1 ± 0.3 |
EH | 0.38 ± 0.09 | 0.46 ± 0.11* | 0.49 ± 0.10* | 0.60 ± 0.09* | 0.63 ± 0.09* |
C4 hr (ng/ml) | 2.4 ± 0.5 | 2.2 ± 0.5 | 2.0 ± 1.3 | 1.3 ± 0.4* | 0.2 ± 0.4* |
C4 hr ratio | 0.88 ± 0.22 | 0.80 ± 0.36 | 0.56 ± 0.13* | 0.48 ± 0.10* | |
(geometric mean, 90% CI) | 0.86 (0.76,0.96) | 0.75 (0.63,0.89) | 0.55 (0.49,0.61) | 0.47 (0.43,0.52) | |
C5 hr (ng/ml) | 1.9 ± 0.6 | 1.6 ± 0.4 | 1.7 ±1.1 | 1.0 ± 0.2* | 0.9 ± 0.4* |
C5 hr ratio | 0.87 ± 0.23 | 0.90 ± 0.48 | 0.55 ± 0.13* | 0.50 ± 0.17* | |
(geometric mean, 90% CI) | 0.84 (0.74,0.96) | 0.82 (0.68,1.0) | 0.54 (0.48,0.61) | 0.47 (0.41,0.55) | |
IV alfentanil | |||||
Cmax (ng/ml) | 102 ± 37 | 106 ± 35 | 107 ± 23 | 102 ± 27 | 105 ± 26 |
AUC0-∞ (ng •hr •ml−1) | 78.0 ± 30.7 | 61.7 ± 19.4* | 55.5 ± 16.7* | 44.0 ± 15.9* | 37.0 ± 8.5* |
AUC0-∞ ratio | 0.83 ± 0.16* | 0.75 ± 0.15* | 0.59 ± 0.12* | 0.51 ± 0.12* | |
(geometric mean, 90% CI) | 0.81 (0.74,0.90) | 0.73 (0.66,0.82) | 0.57 (0.52, 0.63) | 0.50 (0.44,0.56) | |
CLIV (ml•kg−1•min−1) | 3.7 ± 1.4* | 4.4 ± 1.2* | 4.9 ± 1.4* | 6.3 ± 1.8* | 7.1 ± 1.4* |
Elimination t1/2 (hr) | 1.4 ± 0.5 | 1.2 ± 0.3* | 1.1 ± 0.2* | 1.0 ± 0.2* | 0.8 ± 0.2* |
Vss (L/kg) | 0.35 ± 0.06 | 0.35 ± 0.03 | 0.36 ± 0.03 | 0.39 ± 0.09 | 0.38 ± 0.05 |
EH | 0.24 ± 0.09* | 0.28 ± 0.08* | 0.32 ± 0.09* | 0.40 ± 0.11* | 0.46 ± 0.09* |
C2 hr (ng/ml) | 11.8 ± 5.1 | 8.9 ± 3.5* | 8.2 ± 3.4* | 5.8 ± 3.4* | 4.5 ± 1.8* |
C2 hr ratio | 0.82 ± 0.27* | 0.74 ± 0.23* | 0.51 ± 0.17* | 0.42 ± 0.13* | |
(geometric mean, 90% CI) | 0.78 (0.68,0.91) | 0.71 (0.62,0.82) | 0.48 (0.41,0.57) | 0.40 (0.34,0.46) | |
C4 hr (ng/ml) | 4.4 ± 3.2 | 3.1 ± 2.2* | 2.7 ± 1.9* | 1.4 ± 1.1* | 0.8 ± 0.4* |
C4 hr ratio | 0.77 ± 0.28* | 0.72 ± 0.51* | 0.36 ± 0.15* | 0.24 ± 0.15* | |
(geometric mean, 90% CI) | 0.73 (0.62,0.86) | 0.62 (0.49,0.80) | 0.34 (0.29,0.40) | 0.21 (0.17,0.27) | |
IV alfentanil pupil miosis | |||||
Maximum (mm) | 4.3 ± 0.8 | 4.5 ± 0.8 | 4.4 ± 0.8 | 4.4 ± 0.8 | 4.5 ± 0.9 |
AUEC0-last (mm•hr) | 2.8 ± 2.7 | 2.8 ± 2.3 | 1.7 ± 0.9 | 1.3 ± 1.0 | 2.1 ± 1.4 |
AUEC0-∞ (mm•hr) | 3.7 ± 5.0 | 3.9 ± 4.0 | 2.0 ± 1.2 | 1.5 ± 1.2 | 2.5 ± 1.8 |
AUEC0-∞ ratio | 1.6 ± 1.9 | 1.0 ± 0.8 | 1.0 ± 1.0 | 1.2 ± 1.0 | |
(geometric mean, 90% CI) | 1.1 (0.8, 1.6) | 0.74 (0.51, 1.08) | 0.53 (0.30,0.94) | 0.83 (0.49,1.40) |
All subjects received 1 mg IV MDZ, followed by 15 μg/kg IV ALF. Results are the arithmetic mean ± SD, except AUC ratios and single-point concentration ratios, which are also shown as the geometric mean and 90% confidence interval. Cmax, maximum concentration; AUC0-∞, area under plasma concentration–time curve extrapolated to infinity; CLIV, systemic clearance; t1/2, half-life; Vss, steady-state volume of distribution; EH, hepatic extraction; C4 hr and C5 hr, plasma concentration 4 or 5 hr after dosing; AUEC0-last, area under effect (miosis) curve to last time point measured; AUEC0-∞, area under effect (miosis) curve extrapolated to infinity.
Significantly different from control (p<0.05)