[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design, fasting and fed state bioequivalence study of acipimox capsules in healthy subjects
本试验旨在研究单次空腹和餐后口服安徽省先锋制药有限公司生产的阿昔莫司胶囊(0.25 g)的药代动力学特征;以Pfizer Limited持证、Pharmacia Italia SpA生产的阿昔莫司胶囊(Olbetam®,0.25 g)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The aim of this study was to investigate the pharmacokinetic characteristics of acipimox capsules (0.25 g) produced by Anhui Pioneer Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Acipimox capsules (Olbetam®, 0.25 g) produced by Pharmacia Italia SpA and licensed by Pfizer Limited were used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.