Study on Relative Bioavailability of Fluconazole Capsules in Healthy Volunteers

Objective To study pharmacokinetics and bioavailability of fluconazole in 20 young healthy volunteers.Methods The fluconazole concentrations in plasma were determined by HPLC after a single oral dose of standard formulation and the tested formulation was respectively given to 20 volunteers in randomized cross-over test.Results The concentration-time curves of the two formulations fitted to a one-compartment open model.The C max was (6.22±0.69)mg·L -1 and(6.26±0.62)mg·L -1,T max was(1.78±0.93)h and (1.78±0.75)h;T 1/2ke was (25.99±4.81)h and (26.205±3.13)h;AUC t 0 was (202.22±37.37)mg·h·L -1 and (209.98±34.41) mg·h·L -1,AUC ∞ 0 was (221.77±50.71) mg·h·L -1 and (226.73±37.78) mg·h·L -1,respectively.The pharmacokinetic parameters obtained form the study showed no significant difference between the two formulations(P0.05).The relative bioavailability was (97.74±17.39)% and (98.42±19.46.03)% of tested formulation.Conclusion The results of statistical analysis prove that the two formulations are bioequivalent.