The pharmacokinetics of fluconazole in healthy Chinese adult volunteers: influence of ethnicity and gender.

OBJECTIVE

The purpose of the present study was to investigate and compare the influence of ethnicity (including Han, Mongolian, Korean, Hui and Uygur) and gender on the pharmacokinetics of fluconazole in healthy adult volunteers after administration of 200-mg fluconazole tablet.

METHODS

Ten healthy subjects (five males and five females) of each ethnicity were recruited and given a single 200-mg dose of fluconazole in tablet form. Blood samples were obtained before dosing and at various predetermined time points after administration up to 96 h. Drug levels were measured by high-performance liquid chromatography. The blood concentration-time profiles were analyzed using a non-compartmental approach to estimate the absorption parameters (AUC((0-96)), C(max) and t(max)), the distribution parameter (V(d)) and the disposition parameters (t(1/2) and CL).

RESULTS

Ethnicity did not affect the parameter estimates, but gender did. However, the gender differences in pharmacokinetic parameter could be accounted for by differences in weight. There was a high linear correlation between weight and ln C(max), ln AUC (ln means natural logarithmic transformation), V(d) and CL.

CONCLUSIONS

Ethnicity (Chinese Han, Mongolian, Korean, Hui and Uygur) influences the pharmacokinetics of fluconazole tablet. However, there were statistically significant gender differences in AUC, C(max), V(d) and CL. But these could be accounted for by weight differences. If fluconazole dose-adjustment is deemed necessary, this can be done on a weight basis rather than gender basis.