论文部分内容阅读
目的:评价多潘立酮胶囊(受试制剂)和多潘立酮片(参比制剂)的生物等效性。方法:血清样品采用高效液相色谱法测定。18名男性健康志愿者随机分为2组,自身交叉单剂量口服受试制剂和参比制剂,用DAS2.0程序进行生物等效性评价。结果:受试制剂和参比制剂的t1/2分别为(11.0±5.0)h和(10.8±3.9)h,tmax为(1.0±0.4)h和(0.9±0.3)h,Cmax为(43.8±17.2)μg/L和(40.1±15.6)μg/L,AUC0-t为(248.50±102.44)μg.h/L和(244.26±107.62)μg.h/L,AUC0-∞为(280.16±111.46)μg.h/L和(270.83±108.42)μg.h/L,相对生物利用度为(106.8±29.4)%。结论:2种制剂具有生物等效性。
Objective: To evaluate the bioequivalence of domperidone capsules (test preparations) and domperidone tablets (reference preparations). Methods: Serum samples were determined by high performance liquid chromatography. Eighteen male healthy volunteers were randomly divided into two groups, their own crossover single dose oral test preparation and reference preparation, using the DAS2.0 program for bioequivalence evaluation. Results: The t1 / 2 of test preparation and reference preparation were (11.0 ± 5.0) h and (10.8 ± 3.9) h respectively, the tmax was (1.0 ± 0.4) h and (0.9 ± 0.3) h and the Cmax was (43.8 ± AUC0-t was (248.50 ± 102.44) μg.h / L and (244.26 ± 107.62) μg.h / L respectively, AUC0-∞ was (280.16 ± 111.46) μg / L and (40.1 ± 15.6) μg / μg.h / L and (270.83 ± 108.42) μg.h / L, the relative bioavailability was (106.8 ± 29.4)%. Conclusion: The two preparations are bioequivalent.