[Translation] A single-center randomized, open-label, single-dose, two-period, double-crossover, fasting and fed bioequivalence study of acipimox capsules from Anhui Meilai Pharmaceutical Co., Ltd. and acipimox capsules (trade name: Olbetam) from Pfizer Limited in healthy subjects
以中国健康受试者为试验对象,采用自身交叉对照的试验设计,测定安徽美来药业股份有限公司持证,蚌埠丰原涂山制药有限公司生产的阿昔莫司胶囊给药后血浆中的阿昔莫司在健康受试者体内的血药浓度经时过程,估算相应的药代动力学参数,并以Pfizer Limited持证,Pharmacia Italia SpA生产的阿昔莫司胶囊(商品名:Olbetam®,规格:0.25g)为参比,评价制剂间的生物等效性,并观察阿昔莫司胶囊在中国健康受试者中的安全性。
[Translation] Healthy Chinese subjects were used as the test subjects. A self-crossover design was used to determine the time course of acipimox concentration in plasma after administration of acipimox capsules licensed by Anhui Meilai Pharmaceutical Co., Ltd. and produced by Bengbu Fengyuan Tushan Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Acipimox capsules (trade name: Olbetam®, specification: 0.25g) licensed by Pfizer Limited and produced by Pharmacia Italia SpA were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of acipimox capsules in healthy Chinese subjects.