Relative bioavailability of gemfibrozil capsules in healthy volunteers

Aim: To study the pharmacokinetics and bioavailability of gemfibrozil in 18 young healthy volunteers. Methods:The gemfibrozil concentrations in plasma were determined by HPLC after a single oral dose of the standard formulation and the tested formulation were given to 18 volunteers respectively in randomized cross over test. Results:The concentration time curves of two formulations fitted to a one compartment open model.The C max was (45.24±10.15)mg·L -1 and (43.38±9.84)mg·L -1 ; T max was (2.47±0.93)h and (2.25±0.75)h; T 1/2 was (1.59±0.19)h and (1.75±0.29)h; AUC was (165.79±37.79) mg·h·L -1 and (156.39±32.28)mg·h·L -1 ,respectively.The pharmacokinetic parameters obtained from our studies showed that there was no significant difference between 2 formulations( P 0.05).The relative bioavailability of the tested formulation was (95.55± 11.45)% (77.03%～119.45%). Conclusion:The results of statistical analysis suggest that the 2 formulations are with bioequivalent.