Clinical trial
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Dose (mg)
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Route of administration
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n
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Female (%)
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Mean age [range] (years)
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AUCb (ng×h mL-1)
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CL/F (L h-1) | Cmax (ng mL-1) |
Tmax (h)
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Mendelson et al.50 | 2 | sublingual, solution (3 min hold) | 6 | 16.7 | 29 (21–38) | Predicted | 9.36 | 213.6 | 1.94 | 1.11 |
Observed | 14.3c | 139.9d | 1.60c | 1.25c | ||||||
P/O ratio | 0.65 | 1.53 | 1.21 | 0.89 | ||||||
Mendelson et al.50 | 2 | sublingual, solution (5 min hold) | 6 | 16.7 | 29 (21–38) | Predicted | 9.36 | 213.6 | 1.94 | 1.11 |
Observed | 13.2c | 151.5d | 1.72c | 1.62c | ||||||
P/O ratio | 0.71 | 1.41 | 1.13 | 0.69 | ||||||
Kuhlman et al.41 | 4 | sublingual, solution | 6 | 0.0 | 34.4 (27–40) | Predicted | 17.1 | 233.6 | 3.28 | 1.15 |
Observed | 15.0 | 266.5 | 3.22 | 0.60 | ||||||
P/O ratio | 1.14 | 0.88 | 1.02 | 1.92 | ||||||
Nath et al.27 | 8 | sublingual, solution | 6 | 0.0 | 28 (23–42) | Predicted | 28.9 | 277.0 | 5.19 | 1.14 |
Observed | 34.6 | 230.9 | 6.72 | 1.02 | ||||||
P/O ratio | 0.84 | 1.20 | 0.77 | 1.12 | ||||||
Chawarski et al.25 | 8 | sublingual, solution, m.d. | 18 | 29.5 | 37.8 | Predicted | 35.0 | 239.2 | 6.38 | 1.12 |
Observed | 25.4 | 315.6 | 3.19 | 1.18 | ||||||
P/O ratio | 1.38 | 0.76 | 2.00 | 0.95 | ||||||
Chawarski et al.25 | 12 | sublingual, solution, m.d. | 19 | 29.5 | 37.8 | Predicted | 47.3 | 268.0 | 8.27 | 1.12 |
Observed | 33.7 | 356.0 | 4.50 | 0.98 | ||||||
P/O ratio | 1.40 | 0.75 | 1.84 | 1.14 | ||||||
Chawarski et al.25 | 16 | sublingual, solution, m.d. | 20 | 29.5 | 37.8 | Predicted | 58.1 | 292.8 | 9.80 | 1.12 |
Observed | 36.4 | 439.4 | 4.91 | 1.10 | ||||||
P/O ratio | 1.60 | 0.67 | 2.00 | 1.02 | ||||||
Geo. meane | 1.05 | 0.98 | 1.34 | 1.06 | ||||||
(95% CI) | (0.75–1.46) | (0.72–1.33) | (0.95–1.90) | (0.79–1.41) | ||||||
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. |
aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. | aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. | aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. | aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. | aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. | aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. | aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. | aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. | aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. | aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. | aUnless stated otherwise, observed 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. cValue as reported in the original study, i.e., not obtained through Bayesian estimation. dCalculated following CL/F = Dose/AUC0–∞. eGeometric mean of P/O ratios. |