[Translation] A randomized, open-label, single-dose, four-period, completely repeated crossover, fasting and fed bioequivalence study of tacrolimus capsules in healthy subjects
主要目的:采用单中心、随机、开放、单剂量、四周期、完全重复交叉给药设计评价国药集团川抗制药有限公司生产的他克莫司胶囊(规格:1mg)与Astellas Pharma Co.Ltd.持证的他克莫司胶囊(商品名:普乐可复®/Prograf®,规格:1mg)的药动学参数,评价参比制剂与受试制剂在空腹和餐后条件下的人体生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To evaluate the pharmacokinetic parameters of tacrolimus capsules (specification: 1 mg) produced by Sinopharm Sichuan Kang Pharmaceutical Co., Ltd. and tacrolimus capsules (trade name: Prograf®/Prograf®, specification: 1 mg) certified by Astellas Pharma Co., Ltd. using a single-center, randomized, open, single-dose, four-period, completely repeated crossover design, and to evaluate the bioequivalence of the reference preparation and the test preparation under fasting and postprandial conditions.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.