Bioequivalence Evaluation of Clevidipine Butyrate Fat Emulsion Injection in Healthy Volunteers
Objective:To evaluate the bioequivalence of generic formulation of clevidipine butyrate fat emulsion in healthy subjects.Methods:A total of 32 healthy subjects are enrolled in a randomized,open-lable,single-dose,two period,two-sequence and self-crossover study.Clevidipine butyrate fat emulsion injection is injected by continuous intravenous pump 60 min±1 min,and the administration rate is 6 mg/h(about 12 mL/h).The concentrations of clevidipine and its metabolite H152/81 in whole blood at 26 time points before and after injection are determined by high performance liquid chromatography tandem mass spectrometry.Pharmacokinetic parameters are calculated by Phoenix™ WinNonlin® 8.1.Results:The geometric mean ratio of Cmax of clevidipine and its metabolite H152/81 is 103.39%and 106.49%,the 90%Confidence interval(IC)is 99.07%to 107.90%and 99.07%to 107.90%.The geometric mean ratio of AUC0-t is 104.16%and 103.56%,the 90%IC is 100.64%to 107.81%and 101.44%to 105.73%.The geometric mean ratio of AUC0-∞ is 104.16%and 103.65%,the 90%IC is 100.62%to 107.82%and 101.40%to 105.96%.Conclusion:The generic formulation of clevidipine is bioequivalent to the reference marketed brand in healthy subjects.
NETL
NSTL
万方数据
维普
