口服恩丹西酮胶囊的人体相对生物利用度

Human Relative Bioavailability After Oral Ondansetron Capsule

用HPLC法测定9名健康志愿者分别口服恩丹西酮（ondancetron）片剂和胶囊各8mg后血浆药物浓度。两药的药动学参数分别为：AUC（0-∞）为194.3±28.0和195.7±33.8g／（L·h）Cmax为25.1±4.9和25．8±44pg／L；Tmax为1．5±0．5和1．4±0．5h。结果说明两制剂具有生物等效性。

: In a randomized-cross and auto-paired study, the plasma ondansetron concentrations were determined by HPLCmethod on 9 male healthy volunteers,who had orally taken ondansetron tablet (Zofran) 8mg and capsule 8mg respectively.Pharmacokinetic parameters of two dose-forms were AUC ) 194.3+_ 28.0 and 195.7+_ 33.8llg/(L' h),Cm&x25.1+_4.9 and 25.8+_4.4g/L,Tm&x 1.5± 0.5 and 1.4±0.5h respectively. Relative bioavailability of the capsule formulation was 101 ± 7 % .AUC.,Cm&xand Tmax of thetwo dose-forms, including fitting and measured data, were not significantly different (P>0.05, paired- t test) and bioequivalence wasqualified (p<0.05;bioequivalent test).The data illustrated that the two dose--forms possessed bioequivalence.