[Translation] A single-center, randomized, open-label, two-preparation, single-dose, two-cycle, double-crossover fasting/postprandial bioequivalence trial of valacyclovir hydrochloride tablets in healthy subjects.
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂盐酸伐昔洛韦片(生产厂家:珠海润都制药股份有限公司)与参比制剂盐酸伐昔洛韦片(持证商:The Wellcome Foundation Limited,商品名:Valtrex®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂盐酸伐昔洛韦片和参比制剂盐酸伐昔洛韦片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation valacyclovir hydrochloride tablets (manufacturer: Zhuhai Rundu Pharmaceutical Co., Ltd.) and the reference preparation in the fasting/postprandial state. Pharmacokinetic behavior of valacyclovir hydrochloride tablets (licensee: The Wellcome Foundation Limited, trade name: Valtrex®) in healthy subjects to evaluate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation valacyclovir hydrochloride tablets and the reference preparation valacyclovir hydrochloride tablets in healthy subjects.