[Translation] Single-center, randomized, open-label, single (fasting/fed) oral administration, two preparations, two sequences, two cycles, crossover human bioequivalence of flunarizine hydrochloride capsules in Chinese healthy subjects test
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] Main purpose: To observe Chinese healthy subjects taking a single oral administration of the test preparation flunarizine hydrochloride capsules (specification: 5 mg (calculated as flunarizine)) under fasting/after meals; manufacturer: Zhengzhou Ruikang Pharmaceutical Co., Ltd. ) and the reference preparation flunarizine hydrochloride capsules (trade name: Sibeline®; specification: 5mg (calculated as flunarizine); manufacturer: Xi'an Janssen Pharmaceutical Co., Ltd.; certificate holder: Xi'an Janssen Pharmaceutical Co., Ltd. ) after pharmacokinetic characteristics, to evaluate the bioequivalence of the two preparations in the fasting/fed state.
Secondary purpose: To observe the safety of the test preparation flunarizine hydrochloride capsules and the reference preparation flunarizine hydrochloride capsules (Sibyl®) in Chinese healthy subjects.