[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-agent, two-sequence, two-cycle crossover bioequivalence trial of flunarizine hydrochloride capsules in Chinese adult healthy subjects
考察单次口服5mg(空腹/餐后)受试制剂盐酸氟桂利嗪胶囊(规格:5mg/粒,河南福森药业有限公司生产)与参比制剂盐酸氟桂利嗪胶囊(西比灵,规格:5mg/粒,西安杨森制药有限责任公司生产),在中国成年健康受试者体内的药代动力学特征,评价空腹与餐后状态分别口服两种制剂的生物等效性。
[Translation] To investigate a single oral 5 mg (fasting/after meal) test preparation Flunarizine Hydrochloride Capsules (specification: 5 mg/capsule, produced by Henan Fusen Pharmaceutical Co., Ltd.) and the reference preparation Flunarizine Hydrochloride Capsules (Sibilin, Specification: 5mg/capsule, produced by Xi'an Janssen Pharmaceutical Co., Ltd.), the pharmacokinetic characteristics in Chinese adult healthy subjects, and the bioequivalence of two oral preparations in fasting and postprandial states.