Bioequiavailability of Hydrochloric Itraconazole Capsule in Human Body / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the human body pharmacokinetics and bioequiavailability of two kinds of oral single dose of hydrochloric itraconazole capsules.METHODS:A randomized,crossover study of20healthy volunteers receiving sin-gle oral dose of200mg itraconazole was conducted with in vivo blood concentrations determined by HPLC-fluorescence de-tection.RESULTS:The pharmacokinetic parameters for the testing itraconazole and the reference itraconazole were as fol-lows,t 1/2 were(29.3?5.62)h and(29.3?5.81)h,respectively;C max were(81.4?60.0)?g/L and(77.8?45.2)?g/L,respec-tively;t max were(3.9?0.70)h and(4.2?0.70)h,respectively;AUC 0～72 were(1199.4?649.6)(?g?h)/L and(1174.3?701.9)(?g?h)/L,respectively;AUC 0～∞ were(1414.0?815.2)(?g?h)/L and(1386.1?735.8)(?g?h)/L,respectively.there were no significant differences in main pharmacokinetics parameters between2preparations,except in t max from analysis of variance and one-side&two-sides t-tests.The relative bioavailability of trial itraconazole capsule was(105.3?23.4)%.CONCLUSION:These two kinds of itraconazole capsules are bioequivalent.