[Translation] A randomized, open-label, three-period, three-sequence, partial repeat crossover, human bioequivalence study of a single oral administration of sacubitril-valsartan sodium tablets in healthy subjects under the condition of high-fat postprandial administration
主要目的:以药代动力学参数为终点指标,比较高脂餐后给药条件下,合肥合源药业有限公司生产的沙库巴曲缬沙坦钠片与Novartis Pharma Schweiz AG原研进口的沙库巴曲缬沙坦钠片(商品名:诺欣妥®)在健康成年人群中吸收程度和速度的差异,对两制剂的生物等效性进行评价。
次要目的:评价高脂餐后给药条件下,合肥合源药业有限公司生产的沙库巴曲缬沙坦钠片在健康成年人群中的安全性。
[Translation] Main purpose: To compare the sacubitril valsartan sodium tablets produced by Hefei Heyuan Pharmaceutical Co., Ltd. The differences in the degree and speed of absorption of Cubatril-Valsartan Sodium Tablets (trade name: Nuoxintuo®) in healthy adults were evaluated to evaluate the bioequivalence of the two preparations.
Secondary purpose: To evaluate the safety of sacubitril and valsartan sodium tablets produced by Hefei Heyuan Pharmaceutical Co., Ltd. in healthy adults under the condition of high-fat postprandial administration.