Pharmacokinetics and Safety of Duloxetine Enteric-coated Tablets in Chinese Healthy Volunteers: A Randomized Open-label Single- and Multiple-dose Study

摘要

ObjectiveDuloxetine hydrochloride is a selective serotonin (5-hydroxytryptamine) and norepinephrine reuptake inhibitor. It is approved for effective treatment for major depressive disorder. The pharmacokinetics (PK) of duloxetine has been studied, but few pharmacokinetics properties in Chinese subjects are available. This study explored the dose proportionality and determined duloxetine levels in human plasma by comparing the PK properties after administration of single or multiple doses in healthy volunteers.