普伐他汀钠片人体生物等效性研究

 目的评价2种普伐他汀钠片在人体内生物等效性。方法采用随机交叉试验设计,18名健康男性受试者分别单剂量po2种普伐他汀钠片40mg,HPLC-MS法测定血浆中普伐他汀的浓度。结果受试制剂与参比制剂的c_max分别为(77.45±40.55)和(80.48±54.53)ng·mL^-1,t_max分别为(0.94±0.28)和(0.87±0.22)h,t_1/2分别为(2.26±0.89)和(2.29±0.90)h,AUC_0～8分别为(142.74±69.51)和(134.57±72.50)ng·h·mL^-1,AUC_0～∞分别为(155.98±76.49)和(147.72±80.11)ng·h·mL^-1。受试制剂相对于参比制剂的生物利用度为(112.5±38.5)%。结论两制剂具有生物等效性。

Study on bioequivalence of pravastatin sodium tablets in healthy volunteers

OBJECTIVE To evaluate the bioequivalence of Uvo pravastatin sodium tablets in healthy volunteers.METHODS In a randomized crossover study, 18 healthy male volunteers were given a single oral dose of 40 mg pravastatin sodium tablets. Pravastatin in plasma was determined by a HPLC-MS method.RESULTS The main pharmacokinetic parameters of the test and the reference tablets were as follows:c_max were (77.45±40.55) and (80.48±54.53) ng·mL^-1,t_max were (0.94±0.28) and (0.87±0.22)h,t_1/2 were (2.26±0.89) and (2.29±0.90) h,AUC_0～8 were (142.74±69.51) and (134.57±72.50) ng ·h ·mL^-1, AUC_0～∞ were( 155.98±76.49) and(147.72±80.11) ng·h·mL^-1, respectively. The relative bioavailability of the test tablets was (112.5±38.5)% . CONCLUSION The two preparations were bioequivalent.