[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of flunarizine hydrochloride capsules in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂盐酸氟桂利嗪胶囊(规格:5mg(以氟桂利嗪计);生产企业:郑州瑞康制药有限公司)和参比制剂盐酸氟桂利嗪胶囊(商品名:西比灵®;规格:5mg(以氟桂利嗪计);生产企业:西安杨森制药有限公司;持证商:西安杨森制药有限公司)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂盐酸氟桂利嗪胶囊和参比制剂盐酸氟桂利嗪胶囊(西比灵®)在中国健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation Flunarizine Hydrochloride Capsules (Specification: 5 mg (calculated as flunarizine); Manufacturer: Zhengzhou Ruikang Pharmaceutical Co., Ltd.) and the reference preparation Flunarizine Hydrochloride Capsules (Trade name: Sibelion®; Specification: 5 mg (calculated as flunarizine); Manufacturer: Xi'an Janssen Pharmaceutical Co., Ltd.; Licensee: Xi'an Janssen Pharmaceutical Co., Ltd.) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary objective: To observe the safety of the test preparation Flunarizine Hydrochloride Capsules and the reference preparation Flunarizine Hydrochloride Capsules (Sibelion®) in healthy Chinese subjects.