A semiphysiological population pharmacokinetic model of agomelatine and its metabolites in Chinese healthy volunteers.

ABSTRACT:

Aims

Agomelatine is an antidepressant for major depressive disorders. It undergoes extensive first-pass hepatic metabolism and displays irregular absorption profiles and large interindividual variability (IIV) and interoccasion variability of pharmacokinetics. The objective of this study was to characterize the complex pharmacokinetics of agomelatine and its metabolites in healthy subjects.

Methods

Plasma concentration-time data of agomelatine and its metabolites were collected from a 4-period, cross-over bioequivalence study, in which 44 healthy subjects received 25 mg agomelatine tablets orally. Nonlinear mixed effects modelling was used to characterize the pharmacokinetics and variability of agomelatine and its metabolites. Deterministic simulations were carried out to in

SUBMITTER: Xie F 

PROVIDER: S-EPMC6475681 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature