Bioequivalence study of eltrombopag 75 mg film-coated tablets under fasting conditions during the Covid-19 pandemic in healthy Caucasian male subjects.

IF 2.8 3区 医学 Q2 PHARMACOLOGY & PHARMACY BMC Pharmacology & Toxicology Pub Date : 2024-10-23 DOI:10.1186/s40360-024-00803-0
Ahmet Inal, Zafer Sezer, Onur Pinarbasli, Burcu Bulut, Martin Reinsch, Wolfgang Martin, Mumtaz M Mazicioglu, Selma Alime Koru
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Abstract

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 Cmax) and extent (area under the concentration-time curve of plasma, or AUC(0-72) and AUC(0-t) of eltrombopag absorption from the test preparation and reference preparation. The 90% confidence intervals (CI) of the ln-transformed AUC(0-72), AUC(0-t), and Cmax of eltrombopag met the bioequivalence requirements of 80.00-125.00%. Both trial preparations had a similar and very satisfactory safety profile.

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健康高加索男性受试者在 Covid-19 大流行期间空腹条件下服用 75 毫克埃曲博帕格薄膜衣片的生物等效性研究。
本研究旨在确定在 COVID-19 大流行期间空腹服用含有艾曲波帕的参比制剂和试验制剂的生物等效性。研究对象为健康的男性白种人。在每个疗程中,按随机顺序给受试者服用一片测试制剂薄膜衣片或一片参考制剂薄膜衣片,相当于 75 毫克埃曲博帕。在预先确定的采血点采集血液样本,以测定艾曲波帕的药代动力学。样本中的艾曲波帕格浓度是通过使用 ESI(-)验证的 LC-MS/MS 技术测定的。研究结果用于计算试验制剂和参比制剂中艾曲波帕的吸收率(最大血浆浓度,或 Cmax)和吸收度(血浆浓度-时间曲线下面积,或 AUC(0-72) 和 AUC(0-t))。艾曲波帕的 ln 变形 AUC(0-72)、AUC(0-t) 和 Cmax 的 90% 置信区间 (CI) 符合 80.00-125.00% 的生物等效性要求。两种试验制剂具有相似且非常令人满意的安全性。
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来源期刊
BMC Pharmacology & Toxicology
BMC Pharmacology & Toxicology PHARMACOLOGY & PHARMACYTOXICOLOGY&nb-TOXICOLOGY
CiteScore
4.80
自引率
0.00%
发文量
87
审稿时长
12 weeks
期刊介绍: BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.
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