[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of valacyclovir hydrochloride tablets (0.5 g) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择The Wellcome Foundation Limited为持证商的盐酸伐昔洛韦片(商品名:维德思®,规格:0.5g(按伐昔洛韦计))为参比制剂,对浙江车头制药股份有限公司持证的受试制剂盐酸伐昔洛韦片(规格:0.5g(按伐昔洛韦计))进行空腹和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速度和吸收程度与参比制剂的差异是否在可接受的范围内,评估两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂盐酸伐昔洛韦片(规格:0.5g(按伐昔洛韦计))和参比制剂盐酸伐昔洛韦片(商品名:维德思®,规格:0.5g(按伐昔洛韦计))的安全性。
[Translation] Main study purpose: According to the relevant provisions of bioequivalence test, valacyclovir hydrochloride tablets (trade name: Veds®, specification: 0.5g (calculated as valacyclovir)) licensed by The Wellcome Foundation Limited were selected as the reference preparation, and the test preparation valacyclovir hydrochloride tablets (specification: 0.5g (calculated as valacyclovir)) licensed by Zhejiang Chetou Pharmaceutical Co., Ltd. were tested for fasting and postprandial human bioequivalence, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary study purpose: To observe the safety of oral administration of the test preparation valacyclovir hydrochloride tablets (specification: 0.5g (calculated as valacyclovir)) and the reference preparation valacyclovir hydrochloride tablets (trade name: Veds®, specification: 0.5g (calculated as valacyclovir)) by healthy volunteers.