[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation, vortioxetine hydrobromide tablets (strength: 10 mg), and the reference preparation, Xindayue® (strength: 10 mg), in healthy adult subjects in the fasting and fed state.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂氢溴酸伏硫西汀片(规格:10 mg,山西远扬医药科技有限公司持证,山东裕欣药业有限公司生产)与参比制剂氢溴酸伏硫西汀片(心达悦®,规格:10 mg,H.Lundbeck A/S生产)在健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂氢溴酸伏硫西汀片(规格:10 mg)和参比制剂氢溴酸伏硫西汀片(心达悦®)(规格:10 mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation vortioxetine hydrobromide tablets (specification: 10 mg, licensed by Shanxi Yuanyang Pharmaceutical Technology Co., Ltd., produced by Shandong Yuxin Pharmaceutical Co., Ltd.) and the reference preparation vortioxetine hydrobromide tablets (Xindayue®, specification: 10 mg, produced by H.Lundbeck A/S) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary purpose of the study is to evaluate the safety of the test preparation vortioxetine hydrobromide tablets (specification: 10 mg) and the reference preparation vortioxetine hydrobromide tablets (Xindayue®) (specification: 10 mg) in healthy subjects.