Zhao Na, Jia Caiyun, Hu Yiting, Sun Xue, Song Haojing, Qiu Bo, Bai Wanjun, Dong Zhanjun
Department of Pharmacy, Hebei General Hospital, Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang, China.
Front Pharmacol. 2025 Mar 21;16:1512857. doi: 10.3389/fphar.2025.1512857. eCollection 2025.
This study aimed to assess how a high-fat diet impacts the pharmacokinetics and safety characteristics of 8 mg Ondansetron hydrochloride tablets among healthy Chinese individuals.
The findings presented here were obtained from a bioequivalence study, in which individuals were randomly assigned to consume Ondansetron hydrochloride tablets either following a meal or subsequent to a high-fat diet containing 978.6 kcal, with 54.6% of the calories derived from fat. The plasma concentrations of Ondansetron were measured through the utilization of high-performance liquid chromatography-mass spectrometry (LC-MS/MS) after collecting blood samples. For the computation of pharmacokinetic parameters, the non-compartmental module from Phoenix WinNonlin Version 8.2 was utilized Additionally, the BE module within WinNonLin was utilized to statistically analyze key pharmacokinetic metrics, including the maximum level of concentration (Cmax), the area beneath the concentration-time curve spanning from zero to the final quantifiable time point (AUC), and the area beneath the concentration-time curve extending from zero to a theoretical limitless point (AUC) in plasma. A total of 53 healthy subjects participated in the study and were divided into a fasted cohort and a postprandial cohort.
Ondansetron had lower Cmax, AUC, and AUCin plasma when taken with food compared to when taken on an empty stomach, with the 90% confidence interval falling outside the acceptable range of 80.00%-125.00%.The occurrence of treatment-related side effects was comparable in both the fasted and postprandial groups, as was the incidence of adverse drug reactions.
The study concluded that the high-fat meal had a notable impact on how Ondansetron is processed in the body. Healthy subjects tolerated all treatments well and safely under both postprandial and fasted conditions.
http://www.chinadrugtrials.org.cn/index.html, identifier CTR20213116.
本研究旨在评估高脂饮食对健康中国个体中8毫克盐酸昂丹司琼片的药代动力学和安全性特征的影响。
此处呈现的研究结果来自一项生物等效性研究，在该研究中，个体被随机分配为在进食后或食用含978.6千卡热量、其中54.6%热量来自脂肪的高脂饮食后服用盐酸昂丹司琼片。采集血样后，通过高效液相色谱-质谱联用仪（LC-MS/MS）测定血浆中昂丹司琼的浓度。为计算药代动力学参数，使用了Phoenix WinNonlin 8.2版本的非房室模块。此外，还使用WinNonLin中的生物等效性模块对关键药代动力学指标进行统计分析，包括血浆中浓度的最高水平（Cmax）、从零至最终可定量时间点的浓度-时间曲线下面积（AUC）以及从零至理论无限时间点的血浆浓度-时间曲线下面积（AUC）。共有53名健康受试者参与了该研究，并被分为空腹组和餐后组。
与空腹服用相比，进食时服用昂丹司琼后，其血浆中的Cmax、AUC和AUC较低，90%置信区间落在80.00%-125.00%的可接受范围之外。治疗相关副作用的发生率在空腹组和餐后组中相当，药物不良反应的发生率也是如此。
该研究得出结论，高脂餐对昂丹司琼在体内的处理方式有显著影响。健康受试者在餐后和空腹条件下对所有治疗的耐受性良好且安全。
http://www.chinadrugtrials.org.cn/index.html，标识符CTR20213116。
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