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. |