Academy of Military Med Sci, Inst of Toxicology & Pharmacology

Primary objective: To evaluate the effectiveness of enteric-coated amuletine hydrochloride tablets in the treatment of patients with depression; Secondary objective: To evaluate the effectiveness and safety of enteric-coated amuletine hydrochloride tablets in the treatment of patients with depression; Exploratory objective: To understand the population pharmacokinetic characteristics of amuletine hydrochloride;

The primary objective of the clinical trial to evaluate the effect of food on the pharmacokinetics of Amuocetine Hydrochloride Enteric-coated Tablets in healthy subjects was to evaluate the effect of food on the pharmacokinetic characteristics of Amuocetine Hydrochloride Enteric-coated Tablets, and the secondary objective was to evaluate the safety and tolerability of Amuocetine Hydrochloride Enteric-coated Tablets after a single oral administration in Chinese healthy subjects in the fasting and fed states.

The primary objective is to evaluate the effectiveness of enteric-coated amuletine hydrochloride tablets in the treatment of depression. The secondary objective is to evaluate the effectiveness, safety, potential efficacy and predictive biomarkers, population pharmacokinetic characteristics, and plasma drug concentration characteristics of enteric-coated amuletine hydrochloride tablets in the treatment of patients with depression.