Faculty of Medicine, Department of Pharmacology, Hakan Cetinsaya Good Clinical Practise and Research Center, Erciyes University, Kayseri, Türkiye.
ILKO Pharmaceuticals, Ankara, Türkiye.
BMC Pharmacol Toxicol. 2024 Oct 23;25(1):80. doi: 10.1186/s40360-024-00803-0.
This study aims to determine the bioequivalence of the reference preparation and the test preparation containing eltrombopag when both were given during the COVID-19 pandemic while fasting. Participants in the research were healthy male Caucasian subjects. One film-coated tablet of the test preparation or one film tablet of the reference preparation, equivalent to 75 mg of eltrombopag, was given to the participants in a randomized order throughout each treatment session. At pre determined blood sampling points, blood samples were taken to determine the pharmacokinetics of eltrombopag. Eltrombopag concentrations in the samples were determined using an LC-MS/MS technique verified using ESI(-). The study results were used to calculate the rate (the maximum plasma concentration, or C) and extent (area under the concentration-time curve of plasma, or AUC and AUC of eltrombopag absorption from the test preparation and reference preparation. The 90% confidence intervals (CI) of the ln-transformed AUC, AUC, and C of eltrombopag met the bioequivalence requirements of 80.00-125.00%. Both trial preparations had a similar and very satisfactory safety profile.
本研究旨在确定在 COVID-19 大流行期间空腹给予含有艾曲波帕的参比制剂和受试制剂时的生物等效性。研究对象为健康的男性白种人。在每个治疗期内，以随机顺序给予研究参与者一片受试制剂的薄膜包衣片或一片参比制剂的薄膜片，相当于 75mg 的艾曲波帕。在预先确定的采血点采集血样，以确定艾曲波帕的药代动力学。使用经过 ESI(-)验证的 LC-MS/MS 技术测定样品中的艾曲波帕浓度。研究结果用于计算从受试制剂和参比制剂吸收的艾曲波帕的速率（最大血浆浓度或 C）和程度（血浆浓度时间曲线下面积，或 AUC 和 AUC）。ln 转换后的艾曲波帕 AUC、AUC 和 C 的 90%置信区间（CI）符合 80.00-125.00%的生物等效性要求。两种试验制剂均具有相似且非常满意的安全性特征。
