硫酸氨基葡萄糖胶囊在中国健康人体内的生物等效性试验

目的:评价空腹单剂量口服硫酸氨基葡萄糖胶囊受试制剂与参比制剂在中国健康人体中的生物等效性.方法:本研究采用随机、开放、单剂量、三周期、部分重复、三交叉试验设计,共入组健康男性和女性30例,单剂量空腹口服受试制剂和参比制剂硫酸氨基葡萄糖胶囊0.25 g.采用LC-MS/MS测定给药后血浆氨基葡萄糖药物浓度.使用WinNo...

Bioequivalence of glucosamine sulfate capsules after single dose in healthy volunteers

Objective: To evaluate the bioequivalence of reference and test formulations of glucosamine sulfate capsules after single dose in healthy Chinese volunteers under fasting condition. Methods: A total of 30 healthy human volunteers participated in a randomized,open,single-dose,three-cycle,partial repeated,three-crossover study. Volunteers were given single dose( 0. 25 g) of tested and reference formulations of glucosamine sulfate capsules under fasting state. Plasma concentration of glucosamine after administration was analyzed by LC-MS/MS method.Non-compartmental pharmacokinetics parameters were calculated by Win Nonlin 6. 3,and bioequivalence was evaluated using reference-scaled average bioequivalence( RSABE) method by SAS 7. 1. Results: For test and reference formulations,Cmax of glucamine( after baseline correction) were( 585. 0 ± 282. 2) and( 641. 0 ± 293. 6) ng·mL^-1,Tmaxwere 1. 5( 0. 5,5. 0) and 1. 5( 0. 5,5. 0) h,t1/2 were( 1. 8 ± 1. 4) and( 1. 5 ± 0. 5) h,AUC0~twere( 2 089. 2 ±749. 5) and( 2 298. 2 ±928. 4),AUC0 ~ ∞were( 2 095. 3 ± 749. 7) and( 2 303. 1 ± 929. 0),respectively.The geometric mean ratios( GMR) of AUC0~t,AUC0 ~ ∞ and Cmax between test and reference formulations were both within 90% confidence interval broadened bioequivalent rage 74. 9% to 133. 6% and 70. 1% to 142. 7%,and regular bioequivalent range( 80% to 125%). Conclusion: Two formulations were equivalent under fasting condition.