【摘要】 目的:评价两种加替沙星制剂的人体生物等效性。方法:采用两制剂双周期交叉试验设计。18名健康志愿者分别单剂量口服受试制剂加替沙星软胶囊或参比制剂加替沙星片400 mg,采用高效液相色谱法(HPLC)测定血液中药物浓度。结果:受试制剂与参比制剂的Tmax分别为(1.85±0.60)和(2.08±0.65)h,Cmax分别为(3.556±0.904)和(3.575±0.908)μg.mL-1,t1/2分别为(7.76±1.27)和(7.91±1.26)h,AUC0~t分别为(29.71±7.10)和(32.00±7.67)μg.h.mL-1,AUC0~∞分别为(30.91±7.53)和(33.32±8.04)μg.h.mL-1。各药动学参数无显著性统计学差异(P>0.05),加替沙星软胶囊相对生物利用度F为(95.1±16.7)%。结论:2种加替沙星制剂具有生物等效性。更多还原

【Abstract】 Objective: To determine the pharmacokinetics and the relative bioequivalence of two gatifloxacin formulations in Chinese healthy volunteers.Methods: Single oral doses of gatifloxacin soft capsule and tablet were given to 18 volunteers in a two-way crossover design to study the bioequivalence.Gatifloxacin concentrations in the plasma were determined by HPLC.Results: The pharmacokinetic parameters of soft capsule and tablet were as follows: Tmax(1.85±0.60) and(2.08±0.65) h;Cmax(3.556±0.904) and(3.575±0.908) μg·mL-1;t1/2(7.76±1.27) and(7.91±1.26) h;AUC0～t(29.71±7.10) and(32.00±7.67) μg·h·mL-1;AUC0～∞(30.91±7.53) and(33.32±8.04) μg·h·mL-1.The results showed no significant differences between the two formulations(P>0.05).The relative bioavailability of gatifloxacin soft capsule was(95.1±16.7) %.Conclusion: The two gatifloxacin formulations are bioequivalent.更多还原