Y. Yong
2007
Citations
0
Influential Citations
0
Citations
Quality indicators
Journal
Pharmaceutical Journal of Chinese People's Liberation Army
Abstract
Aim To investigate the pharmacokinetics and relative bioavailability of amoxycillin and sulbactam pivoxil test and reference tablets in Chinese healthy volunteers.Methods The study was conducted in a two-treatment,two-period,two-sequence randomized cross-over trial.HPLC and LC/MS/MS were used for the determination of Amoxycillin and Sulbactam in plasma respectively after a single oral dose of Amoxycillin and Sulbactam Pivoxil tablets.The important pharmacokinetic parameters and relative bioavailability were caculated.Results The main pharmacokinetic parameters of test and reference tablets were as follows respectively:Amoxycillin:Cmax was(9.61±2.00)and(10.40±2.87)mg·L-1;Tmax was(1.20±0.28)and(1.21±0.36)h;T1/2 was(1.46±0.86)and(1.13±0.48)h;AUC0-∞ was(23.38±4.04)and(23.04±6.04)mg·h·L-1;AUC0-∞ was(25.28±4.37)and(24.48±5.98)mg·h·L-1;The relative bioavailability of Amoxycillin was(109.3±19.4)%.Sulbactam:Cmax was(7.72±1.43)and(7.85±1.93)mg·L-1;Tmax was(1.71±0.61)and(1.65±0.52)h;T1/2 was(1.93±0.80)and(2.08±0.71)h;AUC0-8 was(26.29±6.62)and(27.54±7.83)mg·h·L-1;AUC0-∞ was(28.51±7.25)and(29.85±8.32)mg·h·L-1;The relative bioavailability of Sulbactam was(98.0±4.6)%.Conclusion The Amoxycillin and Sulbactam Pivoxil test and reference tablets were bioequivalent.