Bioequivalence Study of Budesonide Nebuliser Suspension for Inhalation in Healthy Adult Chinese Trial Participant
Objective:To evaluate the bioequivalence and safety of single-dose budesonide nebuliser suspension between test and reference formulations in healthy adult Chinese trial participants in fasting state.Methods:A single-center,randomized,open-label,four-cycle,two-sequence,and completely repeat-ed crossover design was used.In this study,40 trial participants were randomly assigned into TRTR and RTRT groups.In each period,2 mL∶0.5 mg of the test or reference formulation was nebulized and inhaled orally in fasting state.The concentrations of budesonide in plasma were determined by a validated HPLC-MS/MS method,a noncompartment model of Phoenix WinNonlin(8.3.1)software was used to analyze the pharmacokinetic(PK)parameters of budesonide in plasma and evaluate the bioequivalence of the two formu-lations.All adverse events from administration to the end of follow-up were recorded.Results:The main pharmacokinetic parameters of budesonide in plasma after trial participants inhaled the test and reference formulations in fasting state were respectively as follows:Cmax,(1210±693)and(1020±494)pg·mL-1;AUC0-t,(1660±546)and(1530±477)h·pg·mL-1;AUC0-∞,(1710±554)and(1580±486)h·pg·mL-1;tmax,0.08(0.08,0.75)and 0.08(0.08,0.50)h;t1/2,(3.57±1.26)and(3.31±0.98)h.The 90％confidence intervals for the geometric mean ratios of Cmax,AUC0-t and AUC0-∞ of the test formulation to the reference formulation were 104.75％-121.07％,104.93％-111.38％,and 104.89％-111.22％,respectively,all within the range of 80.00％-125.00％.The incidence of adverse events was 5.0％.Conclusion:In fasting state,the test and reference formulations of budesonide nebuliser suspension have bioequivalence and good safety.
万方数据
维普
