依诺沙星分散片的人体相对生物利用度研究

• 作 者: 韩仰 谭志荣 欧阳冬生 周宏灏
• 机 构: Institute of Clinical Pharmacology Xiangya Medical College Central South University,Institute of Cl
• 出 处: 中国临床药理学与治疗学
• 发表日期: 2007年10期
• 关键词: 依诺沙星 分散片

AIM: To study the relative bioequivalence of fusidic acid suspension and its contrastive suspension. METHODS: A single oral dose of 750 mg domestic fusidic acid suspension, and its contrastive suspension were given to 20 healthy volunteers in an open randomized and two way crossover design. The plasma concentrations were determined by HPLC method. RESULTS: The main pharmacokinetic parameters were as follows: Cmax were (31±5) and (30±6) μg/mL; tmax were (2.0±0.7) and (1.9±0.6) h; AUC0-48 were (43±136) and (436±105) μg·mL-1·h; AUC0-∞ were (460±140) and (451±108) μg·mL-1·h for the reference suspension and the test suspension, respectively. The relative bioavailability of domestic fusidic acid suspension was 100%±13%. CONCLUTION: Statistic analysis shows that the reference preparation and the test preparation were bioequivalent.

AIM: To study the relative bioequivalence of fusidic acid suspension and its contrastive suspension. METHODS: A single oral dose of 750 mg domestic fusidic acid suspension, and its contrastive suspension were given to 20 healthy volunteers in an open randomized and two way crossover design. The plasma concentrations were determined by HPLC method. RESULTS: The main pharmacokinetic parameters were as follows: Cmax were (31 ± 5) and (30 ± 6) μg / mL; ; AUC0-48 were (43 ± 136) and (436 ± 105) μg · mL-1 · h; AUC0-∞ were (460 ± 140) and (451 ± 108) μg · mL- and the test suspension, respectively. The relative bioavailability of domestic fusidic acid suspension was 100% ± 13%. CONCLUTION: Statistic analysis shows that the reference preparation and the test preparation were bioequivalent.