Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers.

ABSTRACT:

Background

The benefit of exogenous melatonin is based on its bioavailability, which depends on the galenic form, the route of administration, the dosage, and the individual absorption and rate of hepatic metabolism.

Objective

The objective of this study is to investigate the bioavailability of melatonin after administration of an oral prolonged-release tablet (PR form) and an immediate-release sublingual spray (IR form). The main metabolite of melatonin, 6-sulfatoxymelatonin (6-SMT), was also measured, which has not been done in previous studies. Its determination is important as an index of the hepatic transformation of melatonin.

Methods

In this single-center, open-label, randomized, crossover study, 14 healthy male volunteers received one tablet of the PR form (1.

SUBMITTER: Ait Abdellah S 

PROVIDER: S-EPMC10439092 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature