[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, completely repeated crossover bioequivalence study of a single oral dose of sacubitril/valsartan sodium tablets in healthy subjects on an empty stomach or after a meal
主要研究目的:研究空腹和餐后状态下单次口服受试制剂沙库巴曲缬沙坦钠片(规格:以沙库巴曲缬沙坦计 100mg(沙库巴曲 49mg/缬沙坦1mg),苏州中化药品工业有限公司生产)与参比制剂沙库巴曲缬沙坦钠片(诺欣妥®,规格:以沙库巴曲缬沙坦计 100mg(沙库巴曲49mg/缬沙坦51mg),Novartis Farma S.p.A.生产, Novartis Pharma SchweizAG 持证)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的:空腹和餐后状态下,研究单次口服受试制剂沙库巴曲缬沙坦钠片和参比制剂沙库巴曲缬沙坦钠片在健康成年受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation sacubitril-valsartan sodium tablets (specifications: 100 mg based on sacubitril-valsartan (sacubitril 49 mg/valsartan 1 mg), produced by Suzhou Sinochem Pharmaceutical Industry Co., Ltd.) and the reference preparation sacubitril-valsartan sodium tablets (Noxinto®, specifications: 100 mg based on sacubitril-valsartan (sacubitril 49 mg/valsartan 51 mg), produced by Novartis Farma S.p.A., licensed by Novartis Pharma SchweizAG) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. The secondary purpose of the study is to study the safety of the test preparation sacubitril-valsartan sodium tablets and the reference preparation sacubitril-valsartan sodium tablets in healthy adult subjects after a single oral administration in the fasting and fed state.