OBJECTIVE To study the
relative bioavailability and the
pharmacokinetics of two kinds of fluconazole
dispersible tablets and fluconazole capsules.METHODS This was an open randomised,three period crossover study on 18 healthy volunteers after a single oral dose of 300 mg fluconazole as two kinds of dispersible tablet(T1),(T2)and capsule(R).A method of high performance liquid chromatography(HPLC) was established to determine the concentrations of fluconazole in plasma. RESULTS The main pharmacokinetics of T1,T2 and R were as following : tmax(1.4±0.5)h,(1.4±0.4)h and(1.6±0.3)h;Cmax(7.949±1.653)mg·L-1,(8.294±2.160)mg·L-1 and(7.882±1.816)mg·L-1;AUC0→96(242.5±69.8)mg·h·L-1,(262.8±88.0)mg·h·L-1 and(242.1±67.2)mg·h·L-1;t1/2 (28.1±7.9)h,(28.8±11.1)h and(28.5±7.9)h.The relative
Bioavailability of test drug was(101.2±16.4)%(T1) and(108.0±14.2)%(T2).The result of ANOVA and two one-side t-test statistical analysis showed that there were no significant differences among T1,T2and R(P>0.05).The 90% confidence interval was in the regulated range.CONCLUSION T1,T2 and R are bioequivalent.