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目的:研究米格列奈钙胶囊(受试制剂)与米格列奈钙片(参比制剂)的生物等效性。方法:20名健康受试者自身交叉单剂量口服米格列奈钙胶囊与米格列奈钙片,采用液相色谱-质谱法测定血浆药物浓度,计算药动学参数,以方差分析与单向t检验进行统计分析。结果:受试制剂和参比制剂的t1/2分别为(1.2±0.3)h和(1.1±0.3)h,tmax分别为(0.6±0.2)h和(0.5±0.3)h,Cmax分别为(838.4±226.6)μg.L-1和(947.3±230.9)μg.L-1,AUC0-12分别为(1 354.0±308.4)ng.h.mL-1和(1 298.8±376.4)ng.h.mL-1。米格列奈钙胶囊相对于片剂的生物利用度为(108.5±24.2)%。结论:2种制剂具有生物等效性。
Objective: To study the bioequivalence of mitiglinide calcium capsule (test preparation) and mitiglinide calcium (reference preparation). Methods: Twenty healthy volunteers were randomized to receive oral administration of mitiglinide calcium and mitiglinide calcium respectively. The plasma drug concentration was determined by liquid chromatography-mass spectrometry. The pharmacokinetic parameters were calculated by ANOVA and single T test for statistical analysis. Results: The t1 / 2 of test preparation and reference preparation were (1.2 ± 0.3) h and (1.1 ± 0.3) h, respectively. The tmax were (0.6 ± 0.2) h and 838.4 ± 226.6) μg · L-1 and (947.3 ± 230.9) μg.L-1, respectively. The AUC0-12 was (1 354.0 ± 308.4) ng.h.mL-1 and (1 298.8 ± 376.4) ng.h respectively. mL-1. The bioavailability of mitomycin calcium capsules relative to the tablets was (108.5 ± 24.2)%. Conclusion: The two preparations are bioequivalent.