[Translation] A single-center, randomized, open-label, two-period, double-crossover bioequivalence study of tiapride hydrochloride tablets in Chinese healthy volunteers under fasting and fed conditions
主要目的:评价天津中新药业集团股份有限公司新新制药厂的盐酸硫必利片(规格:100mg/片(按硫必利计))与持证商为Sanofi S.p.A.的盐酸硫必利片(规格:100mg/片(按硫必利计),商品名:SEREPRILE®,赛诺菲生产)在健康成年受试者空腹和餐后状态下单次口服给药的人体生物等效性。
次要目的:评价盐酸硫必利片在健康成年受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of single oral administration of sulpride hydrochloride tablets (specification: 100 mg/tablet (calculated as sulpride)) produced by Xinxin Pharmaceutical Factory of Tianjin Zhongxin Pharmaceutical Group Co., Ltd. and sulpride hydrochloride tablets (specification: 100 mg/tablet (calculated as sulpride), trade name: SEREPRILE®, produced by Sanofi) produced by the licensee Sanofi S.p.A. in healthy adult subjects under fasting and fed conditions.
Secondary objective: To evaluate the safety of sulpride hydrochloride tablets in healthy adult subjects.