[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, three-sequence, three-period crossover bioequivalence study of valsartan and amlodipine tablets (I) in healthy Chinese adult subjects
主要目的
以河北仁合益康药业有限公司生产的缬沙坦氨氯地平片(I)为受试制剂,按生物等效性试验的有关规定,与Novartis Farmaceutica S.A,Spain公司生产的缬沙坦氨氯地平片(I)(商品名:Exforge,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的
观察受试制剂缬沙坦氨氯地平片(I)和参比制剂缬沙坦氨氯地平片((Exforge)在健康受试者中的安全性。
[Translation] Main purpose
The valsartan amlodipine tablets (I) produced by Hebei Renhe Yikang Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the absorption rate and degree of valsartan amlodipine tablets (I) produced by Novartis Farmaceutica S.A., Spain (trade name: Exforge, reference preparation) were compared in healthy humans to investigate the bioequivalence of the two preparations.
Secondary purpose
To observe the safety of the test preparation valsartan amlodipine tablets (I) and the reference preparation valsartan amlodipine tablets ((Exforge)) in healthy subjects.