Bioequivalence study of pazopanib tablets in Chinese healthy male volunteers under fasting conditions
Objective To study the bioequivalence of the single oral test pazopanib tablets and reference pazopanib tablets(Votrient®)in Chi-nese healthy male volunteers under fasting conditions.Methods This was a multiple-dose,randomized,open-label,double-sequence,two-period,crossover designed study.A total of 60 Chinese healthy male volunteers were enrolled under fasting condition.Volunteers were randomly divided into two groups(T-R group and R-T group),single oral test formulation and reference formulation 800 mg(4 tablets).The plasma concentrations of pazopanib were determined by a validated LC-MS/MS method.The pharmacokinetic parameters were calculated with WinNonlin® 6.4 and the bioequivalence was evaluated through SAS 9.3 software.Results After the volunteers administrated test and reference formulations under fasting conditions,the pharmacokinetic parameters of pazopanib as follows:Cmax of(16 134.53±5 951.79)and(15 098.95±6 077.85)ng/ml,AUC0-t of(482 450.36±176 275.65)and(456 248.86±162 680.93)ng·h/ml,AUC0-∞ of(661 654.07±261 570.69)and(629 932.24±238 932.37)ng·h/ml,respectively.The 90%confidential interval of the geometric mean ratio of Cmax,AUC0-t and AUC0-∞ for the test and reference formulation under fasting conditions were 97.19%～119.86%,95.99%～118.25%,95.34%～117.97%.Conclusion Two kinds of pazopanib tablets are bioequivalent in Chinese healthy male volunteers.
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万方数据
