Bioequivalence study of acetylcysteine granules in healthy subjects
The aim of this study was to evaluate the bioequivalence of domestically developed acetylcysteine granules(T)versus the foreign original developer(R)in fasting and postprandial states in healthy Chinese subjects.The study involved 72 healthy subjects,and designed single-dose,two-period,two-sequence crossover trial.By measuring plasma concentrations of acetylcysteine and calculating the main pharmacokinetic parameters,the results showed that the 90%confidence intervals for the geometric mean ratios of Cmax,AUC0-τ,and AUC0-∞ between T and R under both fasting and postprandial conditions met the bioequivalence criteria.Therefore,it was concluded that T and R were bioequivalent and safe in Chinese healthy subjects under both fasting and postprandial conditions,and could be used interchangeably.
万方数据
维普
