[Translation] A randomized, open-label, two-period, double-crossover, fasting bioequivalence clinical trial of voriconazole dispersible tablets in healthy subjects
主要目的:在空腹状态下,以扬子江药业集团南京海陵药业有限公司生产的伏立康唑分散片(规格:200mg,)为受试制剂,以Pfizer Italia S.r.l.生产的伏立康唑片(威凡®,规格:200mg,)为参比制剂,对比两制剂在健康受试者体内的药代动力学特征,评价两种制剂的生物等效性。
次要目的:观察受试制剂和参比制剂(商品名:威凡®)在健康受试者中的安全性。
[Translation] Primary objective: In the fasting state, voriconazole dispersible tablets (specification: 200 mg,) produced by Nanjing Hailing Pharmaceutical Co., Ltd. of Yangtze River Pharmaceutical Group were used as the test preparation, and voriconazole tablets (Vifan®, specification: 200 mg,) produced by Pfizer Italia S.r.l. were used as the reference preparation to compare the pharmacokinetic characteristics of the two preparations in healthy subjects and evaluate the bioequivalence of the two preparations.
Secondary objective: To observe the safety of the test preparation and the reference preparation (trade name: Vifan®) in healthy subjects.