Study on Bioequivalence of Voriconazole Dispersible Tablets in Healthy Volunteers

OBJECTIVE To study bioequivalence of voriconazole dispersible tablets in healthy volunteers. METHODS A single oral dose (200 mg of test and reference formulation) was given to 20 healthy volunteers in a randomized crossover study. The concentrations of voriconazole in plasma were determined by HPLC. The pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS program.RESULTS After a single dose, the pharmacokinetic parameters for voriconazole were as follows: ρmax were (1 098.25±120.14) and (1 037.01±81.18) μg·L-1; tmax were (1.35±0.29) and (1.70±0.41) h; AUC0-24 were (6 720.05±717.19) and (6 643.92±696.70) μg·h·L-1; AUC0-inf were (7 080.97±747.33) and (7 004.10±794.82) μg·h·L-1 for the test and the reference tablets respectively. The 90% confidential intervals of ρmax,AUC0-24 and AUC0-inf of test formulation to reference formulation were 102.1%～109.2%,95.0%～107.6% and 95.1%～107.7%,respectively. CONCLUSION The relative bioavailability was (102.46±17.08)%,statistic analysis showed that the two formulations were bioequivalence.