| This study provides a comparison between the pharmacokinetic profile and oral bioavailability of a melatonin prolonged-release and a melatonin immediate-release formulation. |
| Bioequivalence of Oniria® and Melatoplus® were not demonstrated based on the differences found in pharmacokinetic measures (Cmax, AUC). |
| Oniria® showed up to three times higher levels of plasma melatonin 4–6 h post-administration. The two-phase release formulation of Oniria enabled melatonin levels to be kept higher than those of peak physiologic melatonin up to 8 h after dosing. |
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