在健康的中国受试者中对Ondansetron化片的生物等价性分析:一个随机的,开放的,两期交叉的I期研究
Caiyun Jia1, Na Zhao1, Haojing Song1
1Department of Pharmacy and Hebei Key Laboratory of Clinical Pharmacy, Hebei General Hospital, No. 348 Heping West Road, Xinhua District, Shijiazhuang City, 050051, Hebei Province, People's Republic of China.
Drugs in R&D
|October 29, 2024
概括
这项研究证实,在禁食和食条件下,丹塞龙化 (HCl) 片具有生物等价性. 这确保通用ondansetron HCl提供了对恶心和吐的缓解的一致有效性.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床药房 临床药房
- 药物开发 药物开发
背景情况:
- 丹塞是一种选择性5-HT3受体抗剂,用于治疗恶心和吐.
- 生物等价性研究对于确保仿制药的疗效与原始产品相匹配至关重要.
研究的目的:
- 为了评估Ondansetron化 (HCl) 片的生物等价性.
- 评估健康受试者在禁食和食后状态下的单剂量管理.
主要方法:
- 随机的,开放的,双循环的,交叉的I期研究.
- 丹塞特朗度在血中的LC-MS/MS分析.
- 使用WinNonLin 8.1软件计算的药用动力学参数.
主要成果:
- 禁食:Cmax,AUC0-t和AUC0-∞的几何平均比 (GMR) 在80-125%的范围内 (83.75-97.79%CI).
- 餐后:Cmax,AUC0-t和AUC0-∞的GMR也在生物等效范围内 (87.35-106.07%CI).
结论:
- 丹塞HCl试验和参考配方表明生物等价性.
- 在健康的成年人中,在禁食和食后条件下,生物等价性得到证实.
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