Table 2.
Melatonin pharmacokinetic parameters. Pharmacokinetic parameters of 1.98-mg prolonged-release tablets (Oniria® from Laboratorios ITF Research Pharma S.L.U, test product in fasting conditions), reference melatonin 1.99 mg (immediate-release tablets, Melatoplus® from Laboratorios Lavigor, in fasting conditions) and endogenous melatonin
| AUC0-inf (h*pg/mL) | AUC0-t (h*pg/mL) | Cmax (pg/mL) | AUC0-2 h (h*pg/mL) | AUC2-11h (h*pg/mL) | t½ (h) | Tmax (h) | Tmax median (range) | ||
|---|---|---|---|---|---|---|---|---|---|
| Oniria® | 8801.42 | 8758.6 | 4155.59 | 4950.25 | 3812.61 | 1.08 | 0.54 | 0.50 (0.25–1.50) | |
| SD | 6279.69 | 6218.14 | 3142.01 | 3342.76 | 2934.8 | 0.38 | 0.34 | ||
| CVe | 71.35 | 70.99 | 75.61 | 67.53 | 76.98 | 35.19 | 62.96 | ||
| Melatoplus® | 7022.74 | 7002.79 | 4179.53 | 4830.32 | 2180.74 | 0.84 | 0.75 | 0.75 (0.25–1.50) | |
| SD | 4381.6 | 4385.25 | 2663.84 | 3248.83 | 1397.98 | 0.14 | 0.4 | ||
| CVe | 62.39 | 62.62 | 63.74 | 67.26 | 64.11 | 16.67 | 53.33 | ||
| Endogenous profile | 729.4 | 701.44 | 91.73 | 13.56 | 1.62 | Not calculated | 5.82 | 5.50 (2.50–10.00) | |
| SD | 331.11 | 340.82 | 42.71 | 21.81 | 6.06 | 2.30 | |||
| CVe | 45.39 | 48.59 | 46.56 | 160.91 | 374.17 | 39.52 | |||
AUC0-2 h area under the time versus drug concentration curve from hour 0 to hour 2 post-administration, AUC2-11h area under the time versus drug concentration curve from hour 2 to hour 11 post-administration, AUC0-inf area under the time versus drug concentration curve from 0 to infinity, AUC0-t area under the time versus drug concentration curve from 0 to the last observation calculated according to the linear trapezoidal rule, Cmax observed maximum plasma drug concentration, CVe coefficient of variation, SD standard deviation, t½ half-life, Tmax time to reach Cmax