费克苏普拉赞10毫克的比较药理动力学研究:证明与参考配方的生物等价性并评估稳定状态
Wonsuk Shin1,2, A-Young Yang1,2, Hyung Park3
1Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13520, Gyeonggi-do, Republic of Korea.
Pharmaceuticals (Basel, Switzerland)
|August 26, 2023
概括
这项研究评估了fexuprazan 10 mg的药理动力学和生物等价性. 发现四片10毫克片与一片40毫克片具有生物等价性,支持其用于与酸有关的疾病.
科学领域:
- 药理学 药理学是指药理学的学科.
- 胃肠病学 胃肠病学
背景情况:
- 费克苏普拉桑是一种与竞争的酸阻塞剂,用于与酸有关的疾病.
- 已知fexuprazan 10 mg的有效性,但每日两次剂量的药理动力学 (PKs) 和与40 mg配方的生物等价性尚未得到证实.
研究的目的:
- 评估单次和多次口服剂量fexuprazan 10 mg的PKs.
- 确定四个fexuprazan 10mg片和一个fexuprazan 40mg片之间的生物等价性.
主要方法:
- 第1部分:对8名健康参与者进行单剂和多剂费克苏普拉桑10毫克的单剂和多剂PK研究.
- 第2部分:单剂量,2x2交叉生物等价性研究,比较24名参与者中的4个fexuprazan 10 mg片和1个40 mg片.
主要成果:
- 多次10毫克剂量导致Cmax和AUC0-12h与单次剂量相比大约翻了一番.
- Cmax和AUC_last的几何平均比率 (90%CI) 分别为1.0290 (0.9352-1.1321) 和1.0290 (0.9476-1.1174),符合生物等价性标准.
结论:
- 对于单次和多次服用fexuprazan 10 mg观察到有利的PKs.
- 四个fexuprazan 10毫克片是生物相当于一个fexuprazan 40毫克片.
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