[Translation] An open, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study of cephalexin capsules in healthy volunteers under fasting and fed conditions
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] Primary objective: To investigate the pharmacokinetic parameters and relative bioavailability of Cephalexin Capsules (test preparation, 125 mg/capsule) produced by Furen Pharmaceutical Group Co., Ltd. and Cephalexin Capsules (reference preparation, Sencephalin®, 125 mg/capsule) produced by Takeda Pharmaceutical Co., Ltd., to conduct a single dose (250 mg) bioequivalence study in humans under fasting and postprandial conditions, and to conduct a post-marketing drug consistency evaluation.
Secondary objective: To observe the safety of the test preparation and the reference preparation after administration in healthy subjects.