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目的评价乌苯美司片剂、胶囊剂在中国人群中的生物等效性。方法采用液相色谱-质谱联用法测定20名健康受试者口服30 mg乌苯美司后血浆中的乌苯美司浓度。采用统计软件计算药动学参数,并评价其生物等效性。结果乌苯美司片剂、胶囊剂的药动学参数AUC0-12 h分别为(3921.9±600.7)和(3879.2±626.7)μg.h.L-1,实测mρax为(2702.4±431.0)和(2582.8±514.8)μg.L-1,实测tmax为(0.58±0.26)和(0.79±0.25)h,t1/2为(2.5±0.5)和(2.1±0.5)h。乌苯美司片剂、胶囊剂的相对生物利用度为(101.5±8.0)%。结论经统计学分析,乌苯美司片剂、胶囊剂具有生物等效性。
Objective To evaluate the bioequivalence of ubenimex tablets and capsules in Chinese population. Methods The concentration of ubenimex in 20 healthy subjects after oral administration of ubenimex was determined by liquid chromatography-mass spectrometry. Pharmacokinetic parameters were calculated using statistical software and their bioequivalence was evaluated. Results Ubenimex tablets and capsules pharmacokinetic parameters AUC0-12 h were (3921.9 ± 600.7) and (3879.2 ± 626.7) μg.hL-1, measured mρax was (2702.4 ± 431.0) and (2582.8 ± 514.8) μg.L-1, tmax was (0.58 ± 0.26) and (0.79 ± 0.25) h and t1 / 2 was (2.5 ± 0.5) and (2.1 ± 0.5) h, respectively. The relative bioavailability of ubenimex tablets and capsules was (101.5 ± 8.0)%. Conclusion By statistical analysis, ubenimex tablets and capsules have bioequivalence.