Study on Pharmacokinetics and Relative Bioavailability of Voriconazole Capsules in Healthy Volunteers

OBJECTIVE To study the pharmacokinetics and relative bioavailability of voriconazole capsules. METHODS A single oral dose of 100 mg voriconazole test capsules and reference tablets was given to 20 healthy male volunteers according to a randomized cross over design. Plasma concentration of voriconazole was determined by HPLC-MS/MS. RESULTS The main pharmacokinetic parameters of test capsules and reference tablets were as follows: T_max(0.75±0.15) and (0.84±0.25)h, C_max (605.4±136.6) and (595.2±134.7)ng·mL^-1, t_1/2 (4.91±1.44) and (5.06±2.06)h, AUC_0-15 (1737.6±325.1) and (1750.6±352.8)ng·h·mL^-1, respectively. Through the one or two-side test for AUC_0-15 and C_max, and T_max with the Wilcoxon test, no significant difference was found. CONCLUSION The two formulations are bioequivalent.