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...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.展开更多
文摘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.
