The pharmacokinetics and safety of enteric-coated duloxetine hydrochloride capsules in healthy Chinese volunteers
Objective:To study the bioequivalence of two enteric-coated duloxetine hydrochloride capsules in healthy Chinese subjects.Methods:This was a single-center,randomized,open,two-cycle,two-sequence,crossover,single-dose trial in healthy adult subjects.A total of 72 healthy subjects were randomly enrolled in the study.The content of duloxetine in human plasma was determined by liquid tandem mass spectrometry,and the pharmacokinetic parameters were evaluated using Phoenix WinNonlin 8.2 software.The bioequivalence of the test and reference preparations was also evaluated.Results:After taking test preparation and reference preparation,Cmax of duloxetine in the fasting group of test preparation and reference preparation were(26.2±8.04)and(26.9±7.30)ng/ml,respectively.AUC0-t were(400.59±206.52)and(411.42±229.82)ng·h/ml,respectively.AUC0-∞were(418.54±225.41)and(429.91±254.89)ng·h/ml,respectively.The kinetic parameters Cmax of duloxetine in the test preparation and the reference preparation group were(24.3±8.51)and(24.9±10.2)ng/ml,respectively.AUC0-t were(400.59±206.52)and(411.42±229.82)ng·h/ml,respectively.AUC0-∞were(418.54±225.41)and(429.91±254.89)ng·h/ml,respectively.The geometric mean ratios of Cmax,AUC0-t,AUC0-∞Cmax,and 90%confidence interval of the two formulations ranged from 80.00%to 125.00%.Conclusion:The two kinds of duloxetine hydrochloride enteric-coated capsules have bioequivalence and good safety in healthy Chinese subjects.
NETL
NSTL
万方数据
