在健康志愿者中对Palbociclib药片的生物等价性研究
Yiting Hu1, Na Zhao1, Haojing Song1
1Department of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, People's Republic of China.
在健康的志愿者中,Palbociclib在禁食和食条件下表现为生物等效. 这项研究证实了试验和参考配方的可互换性,确保了一致的治疗结果.
科学领域:
- 药物动力学和药物生物等价性
- 临床药理学
- 制药科学
背景情况:
- 帕尔博西克利布是针对某些乳腺癌的关键向治疗.
- 确定生物等效对于仿制药的批准和治疗互换性至关重要.
- 了解食物对药物吸收的影响对于优化剂量方案至关重要.
研究的目的:
- 与参考配方相比,评估palbociclib试验配方的生物等价性.
- 评估食物摄入 (食与禁食) 对palbociclib药理学特征的影响.
- 确保palbociclib配方的安全性和有效性.
主要方法:
- 在68名健康志愿者中进行了一项随机的,开放的,两种治疗,两种序列的交叉生物等价性研究.
- 使用高性能液态染色体质谱法 (HPLC- MS) 确定了帕尔博西克利布的血度.
- 使用非分区分析 (NCA) 和生物等效 (BE) 统计方法分析了包括Cmax,AUC0- t和AUC0- ∞在内的药理学参数.
主要成果:
- 在空腹和食条件下,Cmax,AUC0- t和AUC0- ∞的几何平均比 (T/ R) 均处于公认的生物等效范围 (80- 125%).
- 具体来说,在禁食条件下,这些比例分别为97.96%,96.16%和96.02%.
- 在食条件下,这些比率分别为95. 47%,96. 49%和96. 36%,在不同组的不良事件中没有显著差异.
结论:
- 在禁食和食条件下,palbociclib的试验和参考配方是生物等效的.
- 这项研究证实,摄入食物不会显著改变palbociclib的生物等价性.
- 两种palbociclib配方均表现出良好的安全性,在两组中观察到相似的不良事件率.
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