Pharmacokinetics and bioequivalence of paracetamol suspension in Chinese healthy volunteers
Objective:To evaluate the bioequivalence between a single test and reference dose of Paracetamol Suspension in healthy volunteers under the fasting and fed conditions.Methods:A randomized,open label,single-dose,self-crossover design was performed.HPLC-MS/MS was applied to detect the concentrations of acetamidophenol in the plasma of healthy subjects under the fasting and fed conditions.Phoenix WinNonlin 8.1 and SAS 9.4 software were used for PK parameters calculation and bioequivalence analysis.Results:Under the fasting condition,13 healthy subjects were administered by test and 13 by reference preparation.The ratio of the geometric mean and 90%confidence interval of Cmax,AUC0～t and AUC0～∞ are 100.72%(90.88%,111.63%),96.55%(92.80%,100.46%),95.58%(92.78%,98.48%),respectively.All the data fell within the equivalent range of 80.0%～125.00%.Under the fed condition,13 healthy subjects were administered by test and 13 by reference preparation.The ratio of the geometric mean and 90%confidence interval of Cmax,AUC0～t and AUC0～∞are 96.69%(89.52%,104.43%),98.27%(95.63%,100.98%),98.59%(96.01%,101.24%).All the data fell within the equivalent range of 80.0%～125.00%.Conclusion:The two preparations are bioequivalent under fasting and fed conditions.
NETL
NSTL
万方数据
维普
