[Translation] An open-label, randomized, single-dose, two-cycle, two-sequence, crossover fasted and fed state bioequivalence trial of cephalexin capsules in healthy subjects
主要目的:考察辅仁药业集团有限公司生产的头孢氨苄胶囊(受试制剂,125 mg/粒)与Takeda Pharmaceutical Co., Ltd.生产的头孢氨苄胶囊(参比制剂,Sencephalin®,125 mg/粒)的药代动力学参数和相对生物利用度,进行空腹和餐后条件下单次服药(250 mg)的人体生物等效性试验,进行上市后药品一致性评价。
次要目的:观察受试制剂与参比制剂在健康受试者中给药后的安全性。
[Translation] Main purpose: To investigate the cephalexin capsules (test preparation, 125 mg/capsule) produced by Furen Pharmaceutical Group Co., Ltd. and the cephalexin capsules (reference preparation, Sencephalin®, 125 mg/capsule) produced by Takeda Pharmaceutical Co., Ltd. Pharmacokinetic parameters and relative bioavailability of granules), a single dose (250 mg) human bioequivalence test under fasting and postprandial conditions, and a post-marketing drug consistency evaluation.
Secondary objective: To observe the safety of the test product and the reference product after administration in healthy subjects.