| 王倩,赵可新.达沙替尼片在中国健康受试者的生物等效性研究[J].安徽医药,待发表. |
| 达沙替尼片在中国健康受试者的生物等效性研究 |
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| 投稿时间：2022-12-07 录用日期：2023-01-04 |
| DOI： |
| 中文关键词: 达沙替尼 生物等效性 药代动力学 安全性 |
| 英文关键词: |
| 基金项目: |
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| 中文摘要: |
| 目的：评价达沙替尼片受试制剂与参比制剂在中国健康受试者空腹和餐后状态下的生物等效性和安全性。方法：采用单中心、单次给药、随机、开放、两制剂、两周期、交叉设计，空腹试验52名受试者，餐后试验28名受试者，随机分为两组（T-R组，R-T组），每周期给药1次，每次服用50mg达沙替尼片受试制剂或参比制剂，采用LC-MS/MS法测定达沙替尼的血药浓度，由Phoenix WinNonlin（8.2 版本）或SAS（9.4 版本）软件，非房室模型计算药动学参数，进行统计分析，并对受试者的临床观察指标进行安全性评价。结果：受试者空腹试验和餐后试验服用达沙替尼受试制剂和参比制剂Cmax，AUC0-t，AUC0-∞的几何均值比值的90%置信区间在80%~125%范围内，两制剂生物等效。整个试验过程中未发生任何严重不良事件、严重不良反应、导致退出的不良事件或不良反应。结论：达沙替尼片受试制剂和参比制剂在中国健康志愿者空腹和进食条件下具有生物等效性，安全性良好。 |
| 英文摘要: |
| Objective: To evaluate the bioequivalence and safety of the dasatinib tablet test preparations and the reference preparations in the fasting and postprandial conditions in the healthy Chinese subjects. Methods: A single-center, single-dose, randomized, open, two-preparation, two-period, crossover design was used. 52 subjects in the fasting trial and 28 subjects in the postprandial trial were randomly divided into two groups (T-R group and R-T group), and 50 mg of dasatinib test preparation or reference preparation was administered once per period. The plasma concentration of dasatinib was determined by LC-MS/MS, and the pharmacokinetic parameters were calculated by Phoenix WinNonlin (version 8. 2) or SAS (version 9. 4) for statistical analysis, and the safety of clinical observation indexes was evaluated. Results: The 90% confidence interval for the geometric mean ratios of dasatinib and the reference preparations Cmax, AUC0-t, AUC0-∞ in the fasting and postprandial trials was in the range of 80% to 125%, and the two preparations were bioequivalent. There were no serious adverse events, serious adverse reactions, adverse events leading to withdrawal or adverse reactions during the entire trial.Conclusion: The test preparation and reference preparation of dasatinib tablets were bioequivalent and safe under fasting and feeding conditions in Chinese healthy volunteers. |
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