摘要
目的：研究那格列奈分散片在健康人体的药代动力学，并评价其与同剂量制剂间的生物等效性。方法：采用双交叉试验设计，20名健康志愿者口服那格列奈试验和参比制剂90mg，服药后0～12h内间隔取血，用HPLC法测定血药浓度。计算主要药代动力学参数，并以参比制剂计算那格列奈分散片的相对生物利用度，判断其生物等效性。结果：那格列奈分散片试验和参比制剂的体内药代动力学参数Cmax[（3.2±1.03）、（3.3±1.1）mg／L]、Tmax[（3.1±0.6）、（3.4±0.6）h]、T1／2[（3.41±2.24）、（2.86±1.55）h]、Vd／F[（55.614±23.789）、（56.235±38.987）L]、CIMF[（12.011±3.470）、（13.576±4.641）L/h]、AUC0→12[（8.084±2.284）、（7.287±2.111）mg／（h·L）^-1]；受试药那格列奈分散片的相对生物利用度F=（102.4％±17.7％）。结论：两种制剂具有生物等效性。
Objective： To evaluate the pharmacokinetics and bioequivalence of nateglinide dispersible tablet in heshhy subjects. Methods： Randomized cross-over design was adopted , nateglinide and reference preparation 90 mg was taken orally by 20 healthy volunteers in a time; serial blood samples were collected at scheduled intervals in 12 h after that; concentration of nateglinide in plasma was determined using high performance liquid chromatography（HPLC）. The main pharmacokinctic parameters was calculated, the relative bioavailability of nateglinide dispersible tablet was worked out by reference preparation and the bioequivalence was determined. Results： The main pharmacokinctic parameters of nateglinide dispersible tablet and reference preparation were as follow ： Cmax were （3.2 ±1.03） and （3.3 ±1.1） mg/L; Tmax were （3.1 ±0.6） and （3.4 ±0.6） h; T1/2 were （3.41 ±2.24） and （2.86 ±1.55） h; Vd/Fwere （55.614±23.789） and （56.235 ±38.987） L; CL/Fwere （12.011 ±3.470） and （13.576 ±4. 641） L/h; AUC0→12 were （8. 084 ±2. 284） and （7. 287±2.111） mg/（h·L）^-1 ; The relative bioavailability of nateglinide dispersible tablet was 102.4%±17.7% . Conclusion： The two nateglinide preparations are bioequivalent.
出处
《海南医学院学报》
CAS
2008年第3期209-211,共3页
Journal of Hainan Medical University
关键词
降血糖药
药代动力学
生物利用度
色谱法
高压液湘
Hypoglycemic drugs
Pharmacokinetics
Bioavailability
Chromatography. high performance liquid （HPLC）
