[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
研究空腹及餐后状态下单次口服受试制剂沙库巴曲缬沙坦钠片(规格:100mg,裕松源药业有限公司生产)与参比制剂沙库巴曲缬沙坦钠片(诺欣妥®,规格:100mg, Novartis Singapore Pharmaceutical Manufacturing Private.Ltd生产, Novartis Pharma Schweiz AG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] Main study objectives
To study the pharmacokinetics of the test preparation sacubitril-valsartan sodium tablets (specification: 100 mg, produced by Yusongyuan Pharmaceutical Co., Ltd.) and the reference preparation sacubitril-valsartan sodium tablets (Noxinto®, specification: 100 mg, produced by Novartis Singapore Pharmaceutical Manufacturing Private. Ltd., licensed by Novartis Pharma Schweiz AG) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary study objectives
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.