Liu Ze-yuan
2010
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0
Influential Citations
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Quality indicators
Journal
The Chinese Pharmaceutical Journal
Abstract
OBJECTIVE To investigate the pharmacokinetics of rupatadine fumarate tablets.METHODS 12 Healthy volunteers were divided into the groups receiving orally a single dose of 10,20 and 40 mg rupatadine fumarate tablets respectively.The plasma samples were determined by HPLC-MS-MS method.RESULTS The main pharmacokinetic parameters were as follows:ρmax (4.39±1.46),(15.16±7.71) and (27.04±10.92) μg·L-1;tmax (0.78±0.37),(0.94±0.38) and (1.14±0.54)h;t1/2 (7.23±6.35),(10.05±6.43) and (11.53±3.14)h;AUC0-tn (14.14±5.28),(49.28±28.86) and(104.14±45.32) μg·h·L-1;AUC0-∞ (15.18±5.84),(51.59±30.92) and (107.53±46.87)μg·h·L-1 for 10,20 and 40 mg,respectively.CONCLUSION The value of ρmax and AUC were increased in a dose-dependented manner.The pharmacokinetic characteristics of rupatadine fumarate in Chinese healthy volunteers were fitted with linear kinetic model.It is showed that the sex-related differences exist in the main pharmacokinetic parameters between males and females by analysis of variance.