[Translation] A single-center, randomized, open-label, single-dose, four-period, two-sequence, completely repeated crossover, fasting/fed human bioequivalence study of sacubitril/valsartan sodium tablets in healthy Chinese subjects
1、主要目的:采用单中心、随机、开放、单剂量、四周期、两序列、完全重复交叉给药设计评价国药集团致君(深圳)坪山制药有限公司生产的沙库巴曲缬沙坦钠片(规格:200mg)与Novartis Pharma Schweiz AG持证的沙库巴曲缬沙坦钠片(商品名:诺欣妥®,规格:200mg)的药动学参数,评价参比制剂与受试制剂在空腹和餐后条件下的人体生物等效性。
2、次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] 1. Main purpose: To evaluate the pharmacokinetic parameters of sacubitril-valsartan sodium tablets (specification: 200 mg) produced by Sinopharm Zhijun (Shenzhen) Pingshan Pharmaceutical Co., Ltd. and sacubitril-valsartan sodium tablets (trade name: Nuxintu®, specification: 200 mg) certified by Novartis Pharma Schweiz AG using a single-center, randomized, open, single-dose, four-cycle, two-sequence, completely repeated crossover design, and to evaluate the bioequivalence of the reference preparation and the test preparation under fasting and postprandial conditions.
2. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.