目的 评价伊布替尼胶囊受试制剂、参比制剂在空腹、餐后条件下的生物等效性。方法 本研究为空腹和餐后条件下、单中心、随机、开放、两制剂、两序列、四周期、完全重复交叉试验设计生物等效性试验。空腹和餐后分别入组40、32例健康受试者，每周期口服140 mg伊布替尼胶囊受试制剂、参比制剂。采用LC-MS/MS法分析伊布替尼的血药浓度，药动学参数计算由Phoenix WinNonlin 8.3版本软件完成，其他统计分析使用SAS 9.4版本软件完成。结果 健康受试者空腹、餐后状态下药动学参数C_max、AUC_0-t、AUC_0-∞经对数转换后点估计值均完全落入[80.00%，125.00%]。结论 健康受试者空腹、餐后状态下口服伊布替尼胶囊受试制剂和参比制剂具有生物等效性。

Objective To evaluate the bioequivalence of test and reference preparation of Ibrutinib Capsules under fasting and fed condition. Methods A single center, randomized, open label, two-formulation, two-sequence, four-period and completely repeated crossover trial under fasting and fed condition. 40 Cases and 32 healthy subjects were enrolled under fasting and fed condition, respectively, and 140 mg test and reference preparation of Ibrutinib Capsules were taken orally every cycle. The plasma concentration of ibrutinib was analyzed by LC-MS/MS method. Pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.3, and other statistical analysis was performed by SAS 9.4. Results The pharmacokinetic parameters C_max, AUC_0-t, and AUC_0-∞ of healthy subjects under fasting and fed condition all fell within the range of [80.00%, 125.00%] after logarithmic transformation. Conclusion The test or reference product of Ibrutinib Capsules is bioequivalent in healthy volunteers under fasting and fed condition after a single oral administration.

R969.1