米格列奈钙胶囊的人体生物利用度研究

Bioavailability of mitiglinide calcium capsule in Chinese healthy volunteers

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。

ORJECTIVE To study the relative bioequivalence of mitiglinide capsule and mitiglinide tablet in Chinese healthy volunteers. METItODS A single dose of 10 mg mitiglinide was randomly administrated to 20 healthy volunteers in two-way cross-over design. Plasma concentration of mitiglinide was determined by LC-MS method. Pharmacokinetic parameters were calculated. The bioequivalence of the two preparations was calculated by analysis variance and two one side t-test. RESULTS After oral administration, the main pharmacokinetic parameters of test and reference preparations were as follows： t1/2 （1.2± 0. 3） h and（1. 1 ±0.3）h, tmax（0.6± 0.2 ）h and （0. 5± 0.3）h,Cmax（838.4±226.6）μg.L-1 and（947.3± 230.9）μg.L-1,AUC0-12 （ 1 354. 0 ± 308. 4） ng. h. mL-1 and（ 1 298. 8 ± 376. 4） ng. h. mL -1. CONCLUSION The two preparation were bioequivalent.