[Translation] A single-center, randomized, open-label, two-drug, fasting and postprandial, single-dose, four-cycle, repeat-crossover bioequivalence study of valsartan and hydrochlorothiazide tablets
以陕西白鹿制药股份有限公司研制的缬沙坦氢氯噻嗪片(规格:80mg/12.5mg)为受试制剂,持证商为Novartis Pharma Schweiz AG, Switzerland的缬沙坦氢氯噻嗪片(商品名:复代文®,规格:80mg/12.5mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。同时评价两制剂在健康人体中的安全性和耐受性。
[Translation] The Valsartan Hydrochlorothiazide Tablets (specification: 80mg/12.5mg) developed by Shaanxi Bailu Pharmaceutical Co., Ltd. were used as the test preparation, and the licensee was Novartis Pharma Schweiz AG, Switzerland's Valsartan Hydrochlorothiazide Tablets (trade name: Fudai). Wen®, specification: 80mg/12.5mg) as the reference preparation, the pharmacokinetic parameters and relative bioavailability of the two preparations in a single dose in fasting and postprandial states were investigated, and whether the two preparations were bioequivalent . The safety and tolerability of the two preparations in healthy humans were also evaluated.