目的 評(píng)價(jià)伊布替尼膠囊受試制劑、參比制劑在空腹、餐后條件下的生物等效性。方法 本研究為空腹和餐后條件下、單中心、隨機(jī)、開放、兩制劑、兩序列、四周期、完全重復(fù)交叉試驗(yàn)設(shè)計(jì)生物等效性試驗(yàn)。空腹和餐后分別入組40、32例健康受試者，每周期口服140 mg伊布替尼膠囊受試制劑、參比制劑。采用LC-MS/MS法分析伊布替尼的血藥濃度，藥動(dòng)學(xué)參數(shù)計(jì)算由Phoenix WinNonlin 8.3版本軟件完成，其他統(tǒng)計(jì)分析使用SAS 9.4版本軟件完成。結(jié)果 健康受試者空腹、餐后狀態(tài)下藥動(dòng)學(xué)參數(shù)C_max、AUC_0-t、AUC_0-∞經(jīng)對(duì)數(shù)轉(zhuǎn)換后點(diǎn)估計(jì)值均完全落入[80.00%，125.00%]。結(jié)論 健康受試者空腹、餐后狀態(tài)下口服伊布替尼膠囊受試制劑和參比制劑具有生物等效性。

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