吉非罗齐胶囊剂的生物等效性研究

Pharmacokinetics and relative bioavilability of Gemfibrozil capsules in healthy volunteers

目的:对两种吉非罗齐胶囊剂( GEM L 和 GEM X )进行人体相对生物等效性研究。方法: 名健康男性志愿受试者随机交叉单 18剂量口服 600 m g GEM L 或 GEM X ,用高效液相色谱法测定血浆吉非罗齐浓度,经 3P97 生物等效性计算程序处理拟合。结果: GEM L或 GEM X 体内药时曲线符合一室模型, GEM L 或 GEM X 的 Cm ax 分别为 ( 27.01±8.16) μg/m l和 ( 26.71±7.48) μg/m l; ax 分别为 Tm(2.25±0.83)、( h 2.08±0.75); h AUC ( )分别为 ( 0￣T 100.00±21.00) ·h/m l、( μg100.90±22.36) ·h/m l;相对生物利用度为 ( μg 99.12±16.08) % 。结论:经方差分析和单双侧 t检验表明 GEM L 或 GEM X 具有生物等效性。

Objective: To explore the relative bioavailability and pharmacokinetics of Gliclazide capsules(GEML and GEMX)in 18 healthy male volunteers. Methods: A single dose of 600 mg of Gemfibrozil was administered by randomized crossover way in 18 volunteers and the plasma concentrations of Gemfibrozil (Gem)were determined by HPLC. The pharmacokinetic parameters were read with 3P97 pharmacokinetic program and the bioequivalency was evaluated. Results: The concentration-time curves of two preparations fitted to one-compertment model. The peak plasma levels (Cmax) of GEML and GEMX were (27.01±8.16) μg/ml and (26.71±7.48)μg/ml; the peak time (Tmax) was (2.25±0.83)h and (2.08±0.75)h; and AUC (0~T) were (100.00±21.00) μg·h/ml and (100.90±22.36) μg·h/ml. The relative bioavailability was (99.12±16.08)%. Conclusion: The result of two one-side tests suggests that the GEML is bioequivalent to the GEMX.