COMPARATIVE PHARMACOKINETICS OF FLUCONAZOLE AND OF ITRACONAZOLE IN JAPANESE AND IN GERMAN SUBJECTS

In separate but identically designed studies the oral pharmacokinetics of 100 mg doses of the 2 antimycotics fluconazole and itraconazole we re examined in Japanese and German subjects (both n = 12), both fastin g and concomitant to a heavy breakfast. The results with the 2 races w ere compared. With fasting subjects no significant difference was foun d with either antimycotic for any parameter. With fluconazole the phar macokinetic parameters after food were essentially the same for the 2 races. The only significant difference, a delay of 1.5 h in the median t(max) in the Japanese relative to the Germans, should not be of prac tical importance. In contrast, the mean AUC for itraconazole in Japane se subjects after the meal was only 54.9% of the value with Germans (p < 0.05); the corresponding C-max was only 54.7% (p < 0.01). As itraco nazole is normally administered together with food, this suggests that there is a possibility of underdosage in Japanese subjects. There app ears to be no such problem with fluconazole.