Bioequivalence of two venlafaxine hydrochloride capsules in healthy volunteers

Objective:To evaluate the bioequivalence of two venlafaxine hydrochloride capsules.Methods:Single oral dose of two venlafaxine hydrochloride capsules was given to 18 volunteers in an open randomized crossover way to study their pharmacokinetics and relative bioavailability.The venlafaxine concentrations in plasma were determined by reversed phase high performance liquid chromatography.Results:The pharmacokinetic parameters of test and control preparations were as follows:Cmax was(161.76±70.15)vs.(143.22±70.14)ng/ml;Tmax was(3.00±0.84)vs.(2.58±0.86)h;AUC0→t was(917.17±500.72)vs.(834.48±437.99)ng/(h·ml);AUC0→∞ was(1115.46±687.85)vs.(1239.67±861.78)ng/(h·ml);t1/2 was(4.51±1.93)vs.(5.42±3.55)h.90% confidence interval of AUC0→t and Cmax of test preparation ranged from 80.0% to 125.0% and control preparation did from 70.0% to 143.0%,respectively.The relative bioavailability of test preparation was(108.0±27.4)%.Statistical analysis on Tmax showed that there was no significant difference between these two capsules.Conclusion:Test and control preparation were bioequivalent in human body.