Clinical trial
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Dose (mg)
|
Route of administration
|
n
|
Female (%)
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Mean age [range] (years)
|
AUCb (ng×h mL-1)
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CL/F (L h-1) | Cmax (ng mL-1) |
Tmax (h)
|
|
McAleer et al.52 | 2 | sublingual, tablet | 27 | 0.0 | (19–42) | Predicted | 7.32 | 273.1 | 1.37 | 1.14 |
Observed | 10.3 | 195.1 | 1.47 | 1.48 | ||||||
P/O ratio | 0.71 | 1.40 | 0.93 | 0.77 | ||||||
Ciraulo et al.29 | 4 | sublingual, tablet | 23 | 30.4 | 34.5 | Predicted | 15.9 | 252.2 | 2.67 | 1.12 |
Observed | 9.62 | 415.7 | 1.87 | 1.00 | ||||||
P/O ratio | 1.65 | 0.61 | 1.43 | 1.12 | ||||||
Jönsson et al.53 | 4 | sublingual, tablet | 61 | 41.0 | 31.4 (19–54) | Predicted | 13.7 | 291.5 | 2.31 | 1.08 |
Observed | 21.8 | 183.7 | 2.14 | 1.69 | ||||||
P/O ratio | 0.63 | 1.59 | 1.08 | 0.64 | ||||||
Nath et al.27 | 8 | sublingual, tablet | 6 | 0.0 | 28 (23–42) | Predicted | 22.6 | 353.3 | 3.52 | 1.15 |
Observed | 23.5 | 340.5 | 2.95 | 1.10 | ||||||
P/O ratio | 0.96 | 1.04 | 1.19 | 1.05 | ||||||
McAleer et al.52 | 8 | sublingual, tablet | 27 | 0.0 | (19–42) | Predicted | 22.9 | 350.0 | 3.49 | 1.14 |
Observed | 29.1 | 275.3 | 3.84 | 1.27 | ||||||
P/O ratio | 0.79 | 1.27 | 0.91 | 0.90 | ||||||
Ciraulo et al.29 | 8 | sublingual, tablet | 23 | 30.4 | 34.5 | Predicted | 27.1 | 295.0 | 4.15 | 1.12 |
Observed | 20.8 | 384.5 | 2.47 | 0.99 | ||||||
P/O ratio | 1.30 | 0.77 | 1.68 | 1.13 | ||||||
McAleer et al.52 | 12 | sublingual, tablet | 27 | 0.0 | (19–40) | Predicted | 31.0 | 387.4 | 4.35 | 1.15 |
Observed | 41.0 | 292.7 | 4.81 | 1.12 | ||||||
P/O ratio | 0.76 | 1.32 | 0.90 | 1.03 | ||||||
McAleer et al.52 | 16 | sublingual, tablet | 27 | 0.0 | (19–40) | Predicted | 38.2 | 418.7 | 4.98 | 1.15 |
Observed | 52.7 | 303.4 | 6.11 | 0.79 | ||||||
P/O ratio | 0.72 | 1.38 | 0.82 | 1.46 | ||||||
Chawarski et al.25 | 16 | sublingual, tablet, m.d. | 18 | 29.5 | 37.8 | Predicted | 45.5 | 379.0 | 6.68 | 1.12 |
Observed | 31.2 | 512.6 | 3.45 | 0.71 | ||||||
P/O ratio | 1.46 | 0.74 | 1.94 | 1.58 | ||||||
Ciraulo et al.29 | 16 | sublingual, tablet | 23 | 30.4 | 34.5 | Predicted | 45.0 | 355.2 | 5.93 | 1.12 |
Observed | 42.0 | 381.0 | 4.11 | 0.96 | ||||||
P/O ratio | 1.07 | 0.93 | 1.44 | 1.17 | ||||||
Moody et al.54 | 16 | sublingual, tablet, m.d. | 11 | 100.0 | 41.5 | Predicted | 46.8 | 378.2 | 6.87 | 1.00 |
Observed | 57.8 | 276.7 | 6.58 | 0.90 | ||||||
P/O ratio | 0.81 | 1.37 | 1.04 | 1.11 | ||||||
Moody et al.54 | 16 | sublingual, tablet, m.d. | 20 | 0.0 | 35.7 | Predicted | 45.3 | 388.3 | 6.58 | 1.17 |
Observed | 40.9 | 390.8 | 4.54 | 1.05 | ||||||
P/O ratio | 1.11 | 0.99 | 1.45 | 1.11 | ||||||
Jönsson et al.53 | 16 | sublingual, tablet | 64 | 40.6 | 32.1 (20–51) | Predicted | 39.7 | 403.4 | 5.17 | 1.09 |
Observed | 56.3 | 284.1 | 5.29 | 1.54 | ||||||
P/O ratio | 0.71 | 1.42 | 0.98 | 0.71 | ||||||
Chawarski et al.25 | 24 | sublingual, tablet, m.d. | 19 | 29.5 | 37.8 | Predicted | 60.1 | 431.0 | 8.01 | 1.13 |
Observed | 56.8 | 422.2 | 6.86 | 0.91 | ||||||
P/O ratio | 1.06 | 1.02 | 1.17 | 1.24 | ||||||
Ciraulo et al.29 | 24 | sublingual, tablet | 23 | 30.4 | 34.5 | Predicted | 59.5 | 403.5 | 6.81 | 1.13 |
Observed | 61.7 | 389.1 | 5.08 | 0.75 | ||||||
P/O ratio | 0.96 | 1.04 | 1.34 | 1.51 | ||||||
Chawarski et al.25 | 32 | sublingual, tablet, m.d. | 20 | 29.5 | 37.8 | Predicted | 72.2 | 473.8 | 8.76 | 1.13 |
Observed | 55.5 | 576.1 | 6.17 | 0.97 | ||||||
P/O ratio | 1.30 | 0.82 | 1.42 | 1.16 | ||||||
Geo. meanc | 0.96 | 1.07 | 1.20 | 1.07 | ||||||
(95% CI) | (0.82–1.12) | (0.92–1.24) | (1.05–1.37) | (0.94–1.23) | ||||||
AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. | AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. | AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. | AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. | AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. | AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. | AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. | AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. | AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. | AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. | AUC, area under the curve; CI, confidence interval; CL/F, apparent clearance; Cmax, peak concentration; m.d., multiple doses; P/O ratio, ratio between predicted and observed value; Tmax, time to reach Cmax. |
aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. | aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. | aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. | aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. | aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. | aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. | aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. | aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. | aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. | aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. | aObserved pharmacokinetic (PK) parameters were obtained through Bayesian estimation by fitting the buprenorphine population PK model reported by Moore et al.46 to extracted concentration-time profiles. bAUC0–∞ and AUC0–τ for single and multiple dose studies, respectively. cGeometric mean of P/O ratios. |