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目的评价盐酸阿比朵尔胶囊剂在中国健康人体的生物等效性。方法用单剂量口服、随机、开放、双周期交叉设计。将24名健康男性志愿者分为2组,每组12名,分别予以单次空腹口服酸阿比朵尔胶囊试验制剂或参比制剂200 mg。用高效液相色谱-质谱联用法(HPLC-MS/MS)测定血浆中阿比朵尔的药物浓度,用Win Nolin软件计算主要的药代动力学参数,评价试验制剂与参比制剂的相对生物利用度及生物等效性。结果试验制剂和参比制剂的C_(max)分别为(411.93±175.07),(415.08±176.33)ng·m L~(-1);t_(max)分别为(2.13±1.27),(1.74±0.82)h;AUC_(0-t)分别为(2648.33±927.02),(2468.09±710.20)ng·m L~(-1)·h;AUC_(0-∞)分别为(2877.24±946.29),(2713.43±774.14)ng·m L~(-1)·h。以AUC_(0-t)计,试验制剂对参比制剂的相对生物利用度为(107.31±28.27)%。结论盐酸阿比朵尔胶囊的试验制剂与参比制剂具有生物等效性。
Objective To evaluate the bioequivalence of abiraterone hydrochloride capsules in healthy Chinese. Methods A single oral dose, randomized, open, double-cycle cross design. Twenty-four healthy male volunteers were divided into two groups, 12 in each group, and were given a single fasting oral acid Abidol capsule test preparation or reference preparation 200 mg respectively. The drug concentration of abirardone in plasma was determined by HPLC-MS / MS. The main pharmacokinetic parameters were calculated by Win Nolin software to evaluate the relative bioavailability of test and reference preparations Utilization and bioequivalence. Results The maximal values of Cmax for test and reference preparations were (411.93 ± 175.07) and (415.08 ± 176.33) ng · m L -1, respectively; t max were (2.13 ± 1.27) and (1.74 ± 0.82) h; AUC_ (0-t) were (2648.33 ± 927.02) and (2468.09 ± 710.20) ng · m L -1 · h respectively; AUC 0- ∞ were 2877.24 ± 946.29, 2713.43 ± 774.14) ng · m L -1 (-1) h. The relative bioavailability of the test formulation to the reference formulation was (107.31 ± 28.27)% based on AUC_ (0-t). Conclusion The experimental and reference preparations of abiraterone hydrochloride have bioequivalence.