[Translation] A single-center, open-label, randomized, single-dose, single-administration, two-formulation, four-period, complete repeated crossover bioequivalence study of teprenone capsules in healthy subjects in the fasting state and the fed state
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂替普瑞酮胶囊(规格:50 mg,生产厂家:珠海同源药业有限公司)与参比制剂替普瑞酮胶囊(规格:50 mg,持证商:卫材(中国)药业有限公司,商品名:施维舒®)后在中国健康受试者体内的药代动力学行为,评价受试制剂与参比制剂的生物等效性。
次要目的:观察受试制剂替普瑞酮胶囊和参比制剂替普瑞酮胶囊在中国健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation Teprenone Capsules (Specification: 50 mg, manufacturer: Zhuhai Tongyuan Pharmaceutical Co., Ltd.) and the reference preparation Teprenone Capsules (Specification: 50 mg, licensee: Eisai (China) Pharmaceutical Co., Ltd., trade name: Servier®) in healthy Chinese subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary purpose: To observe the safety of the test preparation Teprenone Capsules and the reference preparation Teprenone Capsules in healthy Chinese subjects.