[Translation] To evaluate the single-center, open-label test of the test preparation Vortioxetine Hydrobromide Tablets (specification: 10 mg) and the reference preparation Xindayue® (specification: 10 mg) in healthy adult subjects under fasting and postprandial conditions. Randomized, single-dose, two-cycle, two-sequence, crossover bioequivalence study
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,浙江四维医药科技有限公司生产)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)在健康成年受试者体内的药代动力学,评价空腹和餐后状态下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)在健康成年受试者中的安全性。
[Translation] Main research purpose: To study the test preparation Vortioxetine Hydrobromide Tablets (specification: 10 mg, produced by Zhejiang Siwei Pharmaceutical Technology Co., Ltd.) and the reference preparation Vortioxetine Hydrobromide in single oral administration in fasting and postprandial states. Pharmacokinetics of tablets (Xindayue®) (Strength: 10 mg, produced by H. Lundbeck A/S) in healthy adult subjects, to evaluate the bioequivalence of the two oral preparations in fasting and postprandial states .
Secondary study purpose: To evaluate the effects of the test preparation Vortioxetine Hydrobromide Tablets (Strength: 10 mg) and the reference preparation Vortioxetine Hydrobromide Tablets (Xindayue®) (Strength: 10 mg) in healthy adults. Safety in subjects.