Table 2. Predicted and observed pharmacokinetic parameters of buprenorphine following intravenous (i.v.) administration
Clinical trial
Dose (mg)
Route of administration
n
Female (%)
Mean age [range] (years)
AUC0–∞ (ng×h mL-1)
CL (L h-1)
Cmax (ng mL-1)
Bullingham et al.47 0.3 i.v. (1 min) 5 60 66.8 Predicted 5.96 50.3 1.39
Observed 5.80a 51.8b 0.96
P/O ratio 1.03 0.97 1.45
Bullingham et al.47 0.3 i.v. (1 min) 5 60 64.2 Predicted 4.76 63.0 1.39
Observed 3.14a 95.7b 1.08
P/O ratio 1.52 0.66 1.29
Bullingham et al.47 0.3 i.v. (1 min) 5 60 66.0 Predicted 4.65 64.4 1.38
Observed 3.20a 93.8b 0.95
P/O ratio 1.45 0.69 1.45
Bai et al.48 0.3 i.v. (2 min) 24 24.0 35.5 (20–53) Predicted 4.80 62.5 1.71
Observed 5.20 57.7b 2.32
P/O ratio 0.92 1.08 0.74
Lim et al.49 0.3 i.v. (5 min) 14 NR 25 Predicted 4.53 66.2 1.93
Observed 4.09 77.7 2.73
P/O ratio 1.11 0.85 0.71
Mendelson et al.50 1 i.v. (30 min) 6 16.7 29 (21–38) Predicted 15.8 63.2 13.1
Observed 18.4 62.5 14.3
P/O ratio 0.86 1.01 0.92
Kuhlman et al.41 1.2 i.v. (1 min) 5 0.0 34.4 (27–40) Predicted 19.7 60.8 25.4
Observed 17.4 76.8 37.5
P/O ratio 1.13 0.79 0.68
Huestis et al.51 2 i.v. (1 min) 5 0.0 34.6 (32–39) Predicted 33.3 60.1 15.7
Observed 41.4 49.8 19.3
P/O ratio 0.80 1.21 0.81
Huestis et al.51 4 i.v. (1 min) 5 0.0 34.6 (32–39) Predicted 66.6 60.1 31.4
Observed 75.9 53.2 44.0
P/O ratio 0.88 1.13 0.71
Huestis et al.51 8 i.v. (1 min) 5 0.0 34.6 (32–39) Predicted 133.2 60.1 62.9
Observed 153.3 52.4 85.7
P/O ratio 0.87 1.15 0.73
Huestis et al.51 12 i.v. (1 min) 5 0.0 34.6 (32–39) Predicted 199.8 60.1 94.3
Observed 245.1 54.7 107.9
P/O ratio 0.82 1.10 0.87
Huestis et al.51 16 i.v. (1 min) 5 0.0 34.6 (32–39) Predicted 266.4 60.1 125.8
Observed 269.1 60.0 134.0
P/O ratio 0.99 1.00 0.94
Geo. meanc 1.01 0.95 0.91
(95% CI) (0.90–1.13) (0.84–1.08) (0.78–1.05)
AUC0–∞, area under the curve from zero to infinity; CI, confidence interval; CL, clearance; Cmax, peak concentration; NR, not reported; P/O ratio, fold-difference between predicted and observed values. AUC0–∞, area under the curve from zero to infinity; CI, confidence interval; CL, clearance; Cmax, peak concentration; NR, not reported; P/O ratio, fold-difference between predicted and observed values. AUC0–∞, area under the curve from zero to infinity; CI, confidence interval; CL, clearance; Cmax, peak concentration; NR, not reported; P/O ratio, fold-difference between predicted and observed values. AUC0–∞, area under the curve from zero to infinity; CI, confidence interval; CL, clearance; Cmax, peak concentration; NR, not reported; P/O ratio, fold-difference between predicted and observed values. AUC0–∞, area under the curve from zero to infinity; CI, confidence interval; CL, clearance; Cmax, peak concentration; NR, not reported; P/O ratio, fold-difference between predicted and observed values. AUC0–∞, area under the curve from zero to infinity; CI, confidence interval; CL, clearance; Cmax, peak concentration; NR, not reported; P/O ratio, fold-difference between predicted and observed values. AUC0–∞, area under the curve from zero to infinity; CI, confidence interval; CL, clearance; Cmax, peak concentration; NR, not reported; P/O ratio, fold-difference between predicted and observed values. AUC0–∞, area under the curve from zero to infinity; CI, confidence interval; CL, clearance; Cmax, peak concentration; NR, not reported; P/O ratio, fold-difference between predicted and observed values. AUC0–∞, area under the curve from zero to infinity; CI, confidence interval; CL, clearance; Cmax, peak concentration; NR, not reported; P/O ratio, fold-difference between predicted and observed values. AUC0–∞, area under the curve from zero to infinity; CI, confidence interval; CL, clearance; Cmax, peak concentration; NR, not reported; P/O ratio, fold-difference between predicted and observed values.
aCalculated through noncompartmental analysis. bCalculated following CL = Dose/AUC0–∞. cGeometric mean of P/O ratios. aCalculated through noncompartmental analysis. bCalculated following CL = Dose/AUC0–∞. cGeometric mean of P/O ratios. aCalculated through noncompartmental analysis. bCalculated following CL = Dose/AUC0–∞. cGeometric mean of P/O ratios. aCalculated through noncompartmental analysis. bCalculated following CL = Dose/AUC0–∞. cGeometric mean of P/O ratios. aCalculated through noncompartmental analysis. bCalculated following CL = Dose/AUC0–∞. cGeometric mean of P/O ratios. aCalculated through noncompartmental analysis. bCalculated following CL = Dose/AUC0–∞. cGeometric mean of P/O ratios. aCalculated through noncompartmental analysis. bCalculated following CL = Dose/AUC0–∞. cGeometric mean of P/O ratios. aCalculated through noncompartmental analysis. bCalculated following CL = Dose/AUC0–∞. cGeometric mean of P/O ratios. aCalculated through noncompartmental analysis. bCalculated following CL = Dose/AUC0–∞. cGeometric mean of P/O ratios. aCalculated through noncompartmental analysis. bCalculated following CL = Dose/AUC0–∞. cGeometric mean of P/O ratios.