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目的评价阿比朵尔片与参比制剂(阿比朵尔胶囊)是否等效。方法20名男性健康受试者随机分为2组,交叉口服受试制剂(阿比朵尔片)和参比制剂各200 mg后,以高效液相色谱法测定血浆中药物浓度。所得数据用3P87统计软件进行处理。结果阿比朵尔受试制剂和参比制剂的tmax分别为(1.08±0.61)和(1.63±1.06)h;ρmax分别为(408.5±167.4)和(417.8±240.7)μg.L-1;t1/2分别为(11.77±5.01)和(10.55±4.01)h;用梯形法计算,AUC0-48分别为(2 641.2±1 024.0)和(2 725.8±1 181.0)μg.h.L-1;AUC0-∞分别为(2 751.5±1 197.6)和(2 857.4±1 311.3)μg.h.L-1。以AUC0-48计算,盐酸阿比朵尔片的相对生物利用度平均为(96.9±42.3)%。结论2种制剂具有生物等效性。
Objective To evaluate whether the equivalent of abirardone tablets and reference preparations (abidol capsules). Methods Twenty male healthy volunteers were randomly divided into two groups. The plasma concentration of the drug was determined by HPLC after the oral administration of the test preparation (abidomin tablet) and the reference formulation of 200 mg each. The data obtained is processed using 3P87 statistical software. Results The tmax of the experimental and reference preparations of abidom were (1.08 ± 0.61) and (1.63 ± 1.06) h, respectively; the values of ρmax were (408.5 ± 167.4) and (417.8 ± 240.7) μg.L- / 2 were (11.77 ± 5.01) and (10.55 ± 4.01) h, respectively. AUC0-48 was (2 641.2 ± 1 024.0) and (2 725.8 ± 1 181.0) μg.hL- ∞ were (2 751.5 ± 1 197.6) and (2 857.4 ± 1 311.3) μg.hL-1, respectively. The relative bioavailability of abiraterone hydrochloride tablets was (96.9 ± 42.3)% based on AUC0-48. Conclusion The two preparations have bioequivalence.