Table 2 Mean pharmacokinetic parameters following multiple escalating oral nalbuphine doses in hemodialysis patients
Parameter | Statistics | Non-dialysis days | Dialysis days | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
30 mg BID | 60 mg BID | 120 mg BID | 180 mg BID | 240 mg BID | 30 mg BID | 60 mg BID | 120 mg BID | 180 mg BID | 240 mg BID | ||
Day 4 | Day 6 | Day 9 | Day 13 | Day 15 | Day 3 | Day 7 | Day 10 | Day 12 | Day 14 | ||
AUC tau (ng•h/mL) | n | 14 | 10 | 10 | 9 | 3 | 11 | 10 | 10 | 13 | 3 |
Mean | 117.97 | 221.68 | 621.79 | 760.87 | 769.99 | 118.56 | 255.54 | 582.15 | 646.06 | 539.72 | |
SD | 76.41 | 145.04 | 415.94 | 538.28 | 509.88 | 74.93 | 157.81 | 374.09 | 433.26 | 476.19 | |
CV | 64.8 | 65.4 | 66.9 | 70.7 | 66.2 | 63.2 | 61.8 | 64.3 | 67.1 | 88.2 | |
C max (ng/mL) | n | 14 | 10 | 10 | 9 | 3 | 11 | 10 | 10 | 13 | 4 |
Mean | 13.44 | 24.78 | 70.33 | 82.78 | 80.47 | 12.84 | 27.04 | 62.51 | 69.12 | 63.45 | |
SD | 8.31 | 17.38 | 48.81 | 55.81 | 51.76 | 7.71 | 15.74 | 40.11 | 47.20 | 40.10 | |
CV | 61.8 | 70.1 | 69.4 | 67.4 | 64.3 | 60.1 | 58.2 | 64.2 | 68.3 | 63.2 | |
T max (h) | n | 14 | 10 | 10 | 9 | 3 | 11 | 10 | 10 | 13 | 4 |
Min | 0 | 0 | 3.0 | 2.0 | 3.1 | 2.0 | 0 | 0 | 0 | 0 | |
Median | 4.0 | 5.0 | 6.0 | 5.0 | 9.0 | 4.0 | 4.0 | 3.5 | 3.0 | 2.0 | |
Max | 9.0 | 9.0 | 9.0 | 7.1 | 12.0 | 11.9 | 11.9 | 4.0 | 11.9 | 4.0 | |
AUC d (ng•h/mL) | n | 11 | 10 | 10 | 9 | ||||||
Mean | NA | NA | NA | NA | NA | 40.57 | 86.87 | 194.95 | 280.33 | NA | |
SD | 28.14 | 55.63 | 136.98 | 217.42 | |||||||
CV% | 69.4 | 64.0 | 70.3 | 77.6 | |||||||
%Arem | n | 11 | 10 | 10 | 9 | ||||||
Mean | NA | NA | NA | NA | NA | 0.95 | 1.07 | 1.24 | 1.11 | NA | |
SD | 0.69 | 0.74 | 0.91 | 0.85 | |||||||
CV% | 73.0 | 69.2 | 73.1 | 76.0 | |||||||
CL d a (L/h) | n | 11 | 10 | 10 | 9 | ||||||
Mean | NA | NA | NA | NA | NA | 6.98 | 7.33 | 7.60 | 7.32 | NA | |
SD | 1.40 | 1.16 | 1.30 | 1.04 | |||||||
CV% | 20.1 | 15.8 | 17.1 | 14.2 | |||||||