[Translation] A single-center, randomized, open-label, single-dose, fasting and postprandial, two-formulation, two-sequence, four-period, fully repeated crossover bioequivalence study of sacubitril-valsartan sodium tablets in healthy Chinese adult subjects
主要研究目的:
考察单次口服(空腹/餐后)受试制剂沙库巴曲缬沙坦钠片【规格:以沙库巴曲缬沙坦计200 mg(沙库巴曲97 mg/缬沙坦103 mg),江苏永安制药有限公司生产】与参比制剂【商品名:诺欣妥,规格:以沙库巴曲缬沙坦计200 mg(沙库巴曲97 mg/缬沙坦103 mg),Novartis Farma S.p.A.生产】在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价单次口服(空腹/餐后)受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the relative bioavailability of a single oral (fasting/postprandial) test formulation of sacubitril-valsartan sodium tablets [Specification: 200 mg (sacubitril 97 mg/valsartan 103 mg), produced by Jiangsu Yongan Pharmaceutical Co., Ltd.] and a reference formulation [Trade name: Nusintuo, Specification: 200 mg (sacubitril 97 mg/valsartan 103 mg), produced by Novartis Farma S.p.A.] in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two formulations, evaluate the bioequivalence of the two formulations, and provide a reference for the application and clinical use of the drug.
Secondary study objectives:
To evaluate the safety of a single oral (fasting/postprandial) test formulation and reference formulation in healthy adult Chinese subjects.