Ahmet Inal, Zafer Sezer, Onur Pinarbasli, Burcu Bulut, Martin Reinsch, Wolfgang Martin, Mumtaz M Mazicioglu, Selma Alime Koru
{"title":"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。","authors":"Ahmet Inal, Zafer Sezer, Onur Pinarbasli, Burcu Bulut, Martin Reinsch, Wolfgang Martin, Mumtaz M Mazicioglu, Selma Alime Koru","doi":"10.1186/s40360-024-00803-0","DOIUrl":null,"url":null,"abstract":"<p><p>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<sub>max</sub>) and extent (area under the concentration-time curve of plasma, or AUC<sub>(0-72)</sub> and AUC<sub>(0-t)</sub> of eltrombopag absorption from the test preparation and reference preparation. The 90% confidence intervals (CI) of the ln-transformed AUC<sub>(0-72)</sub>, AUC<sub>(0-t)</sub>, and C<sub>max</sub> of eltrombopag met the bioequivalence requirements of 80.00-125.00%. Both trial preparations had a similar and very satisfactory safety profile.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"25 1","pages":"80"},"PeriodicalIF":2.8000,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515640/pdf/","citationCount":"0","resultStr":"{\"title\":\"Bioequivalence study of eltrombopag 75 mg film-coated tablets under fasting conditions during the Covid-19 pandemic in healthy Caucasian male subjects.\",\"authors\":\"Ahmet Inal, Zafer Sezer, Onur Pinarbasli, Burcu Bulut, Martin Reinsch, Wolfgang Martin, Mumtaz M Mazicioglu, Selma Alime Koru\",\"doi\":\"10.1186/s40360-024-00803-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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<sub>max</sub>) and extent (area under the concentration-time curve of plasma, or AUC<sub>(0-72)</sub> and AUC<sub>(0-t)</sub> of eltrombopag absorption from the test preparation and reference preparation. The 90% confidence intervals (CI) of the ln-transformed AUC<sub>(0-72)</sub>, AUC<sub>(0-t)</sub>, and C<sub>max</sub> of eltrombopag met the bioequivalence requirements of 80.00-125.00%. Both trial preparations had a similar and very satisfactory safety profile.</p>\",\"PeriodicalId\":9023,\"journal\":{\"name\":\"BMC Pharmacology & Toxicology\",\"volume\":\"25 1\",\"pages\":\"80\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2024-10-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515640/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Pharmacology & Toxicology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s40360-024-00803-0\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Pharmacology & Toxicology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s40360-024-00803-0","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Bioequivalence study of eltrombopag 75 mg film-coated tablets under fasting conditions during the Covid-19 pandemic in healthy Caucasian male subjects.
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.
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.