[Translation] Randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover, bioequivalence trial of valsartan capsules (80 mg) under fasting and postprandial dosing conditions
选择北京诺华制药有限公司生产的缬沙坦胶囊(规格:80mg/粒)为参比制剂,对陕西东泰制药有限公司生产的缬沙坦胶囊进行空腹及餐后给药人体生物等效性试验,比较受试制剂中药物的吸收程度和吸收速度与参比制剂的差异是否在可接受的范围内,比较两种制剂在空腹及餐后给药条件下的生物等效性;在受试者中的安全性。
[Translation] Valsartan capsules (specification: 80 mg/capsule) produced by Beijing Novartis Pharmaceuticals Co., Ltd. were selected as the reference preparation, and the valsartan capsules produced by Shaanxi Dongtai Pharmaceutical Co., Ltd. were subjected to fasting and postprandial administration. Human bioequivalence test , compare whether the difference between the absorption degree and absorption rate of the drug in the test preparation and the reference preparation is within an acceptable range, and compare the bioequivalence of the two preparations under the conditions of fasting and postprandial administration; security in.