[Translation] Chinese healthy adult subjects were given a single oral dose of sacubitril and valsartan sodium tablets (24mg/26mg) under fasting and postprandial states. Test preparation (manufactured by Dr. Reddy's Laboratories Limited, India) and reference preparation (Nuoxin A randomized, open-label, two-agent, two-sequence, four-cycle, fully replicated crossover design bioequivalence study
主要研究目的:
研究空腹和餐后状态下单次口服沙库巴曲缬沙坦钠片(24mg/26mg)受试制剂(Dr. Reddy’s Laboratories Limited, India 生产)与参比制剂(诺欣妥®,Novartis Singapore Pharmaceutical Manufacturing Private.Ltd.生产)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,研究单次口服沙库巴曲缬沙坦钠片(24mg/26mg)受试制剂与参比制剂在健康成年受试者中的安全性。
[Translation] Main research purposes:
A single oral dose of sacubitril and valsartan sodium tablets (24mg/26mg) in fasting and postprandial states was studied. The test preparation (manufactured by Dr. Reddy's Laboratories Limited, India) and the reference preparation (Nocinto®, Novartis Singapore Pharmaceutical) were studied. Manufacturing Private. Ltd.) Pharmacokinetics in Healthy Adult Subjects
To evaluate the bioequivalence of the two oral formulations in the fasting and postprandial states.
Secondary research purposes:
To study the safety of a single oral dose of sacubitril and valsartan sodium tablets (24mg/26mg) in healthy adult subjects under fasting and postprandial conditions.