[Translation] A single-center, randomized, open-label, two-dose, single-dose, two-sequence, four-period, completely repeated crossover design bioequivalence study of sacubitril-valsartan sodium tablets developed by Suzhou Dawnray Pharmaceutical Co., Ltd. and sacubitril-valsartan sodium tablets (200 mg, trade name: Entresto®/Noxintu®) from NOVARTIS PHARMA SCHWEIZ AG in healthy Chinese subjects under fasting/fed conditions
以苏州东瑞制药有限公司研制的沙库巴曲缬沙坦钠片(规格:200 mg)为受试制剂,以持证商为NOVARTIS PHARMA SCHWEIZ AG的沙库巴曲缬沙坦钠片(规格:200 mg,商品名:Entresto®/诺欣妥®)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性;同时评价两种制剂在健康人体中的安全性和耐受性
[Translation] The test preparation was Sacubitril-Valsartan Sodium Tablets (200 mg) developed by Suzhou Dongrui Pharmaceutical Co., Ltd., and the reference preparation was Sacubitril-Valsartan Sodium Tablets (200 mg, trade name: Entresto®) from NOVARTIS PHARMA SCHWEIZ AG. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.