Bioequivalence Study of Multiple Dose Steady State Diclofenac Sodium Extended-Release Tablets in Human

Objective: To study the bioequivalence of multiple dose steady state Diclofenac Sodium extended-release tablets in human.Method: Imported extended-release tablets Voltaren was adopted as reference standard.Assess the bioequivalence of Diclofenac Sodium extended-release tablets self-made through the blood drug concentrations and the fluctuation coefficient in 8 male healthy volunteers after multiple dose administration and reaching steady state.8 male healthy volunteers were divided into A group,B group and self-controlled.The plasma drug concentrations were measured by HPLC and the pharmacokinetic parameters were counted following the test and reference preparations respectively given to them with an interval of one week.Result: The blood drug concentration fluctuation of steady state test preparation was(3.1±1.5),while that of reference preparation was(3.1±0.7).The relative bioavailability was(97.6±22.7)%.Conclusion: Diclofenac Sodium extended-release tablets self-made was bioequivalent to imported extended-release tablets Voltaren.