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 preparat...
Saved in:
| Published in | BMC pharmacology & toxicology Vol. 25; no. 1; p. 80 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London
BioMed Central
23.10.2024
BioMed Central Ltd |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2050-6511 2050-6511 |
| DOI | 10.1186/s40360-024-00803-0 |
Cover
| 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 C
max
) 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 C
max
of eltrombopag met the bioequivalence requirements of 80.00–125.00%. Both trial preparations had a similar and very satisfactory safety profile.
Key points
• Bioequivalence of eltrombopag film-coated tablets
• Safety evaluation of eltrombopag film-coated tablets |
|---|---|
| AbstractList | 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) and extent (area under the concentration-time curve of plasma, or AUC.sub.(0-72) and AUC.sub.(0-t) of eltrombopag absorption from the test preparation and reference preparation. The 90% confidence intervals (CI) of the ln-transformed AUC.sub.(0-72), AUC.sub.(0-t), and C.sub.max of eltrombopag met the bioequivalence requirements of 80.00-125.00%. Both trial preparations had a similar and very satisfactory safety profile. Keywords: Bioequivalence study, Eltrombopag, Pharmacokinetic, Bioavailability 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. 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 max ) 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 C max of eltrombopag met the bioequivalence requirements of 80.00–125.00%. Both trial preparations had a similar and very satisfactory safety profile. Key points • Bioequivalence of eltrombopag film-coated tablets • Safety evaluation of eltrombopag film-coated tablets 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) and extent (area under the concentration-time curve of plasma, or AUC.sub.(0-72) and AUC.sub.(0-t) of eltrombopag absorption from the test preparation and reference preparation. The 90% confidence intervals (CI) of the ln-transformed AUC.sub.(0-72), AUC.sub.(0-t), and C.sub.max of eltrombopag met the bioequivalence requirements of 80.00-125.00%. Both trial preparations had a similar and very satisfactory safety profile. 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. • Bioequivalence of eltrombopag film-coated tablets• Safety evaluation of eltrombopag film-coated tablets 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.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. 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. |
| ArticleNumber | 80 |
| Audience | General |
| Author | Mazicioglu, Mumtaz M. Pinarbasli, Onur Martin, Wolfgang Sezer, Zafer Inal, Ahmet Koru, Selma Alime Bulut, Burcu Reinsch, Martin |
| Author_xml | – sequence: 1 givenname: Ahmet surname: Inal fullname: Inal, Ahmet email: ainal@erciyes.edu.tr organization: Faculty of Medicine, Department of Pharmacology, Hakan Cetinsaya Good Clinical Practise and Research Center, Erciyes University – sequence: 2 givenname: Zafer surname: Sezer fullname: Sezer, Zafer organization: Faculty of Medicine, Department of Pharmacology, Hakan Cetinsaya Good Clinical Practise and Research Center, Erciyes University – sequence: 3 givenname: Onur surname: Pinarbasli fullname: Pinarbasli, Onur organization: ILKO Pharmaceuticals – sequence: 4 givenname: Burcu surname: Bulut fullname: Bulut, Burcu organization: ILKO Pharmaceuticals – sequence: 5 givenname: Martin surname: Reinsch fullname: Reinsch, Martin organization: Analytisches Zentrum Biopharm GmbH – sequence: 6 givenname: Wolfgang surname: Martin fullname: Martin, Wolfgang organization: Pharmakin Consulting Services UG – sequence: 7 givenname: Mumtaz M. surname: Mazicioglu fullname: Mazicioglu, Mumtaz M. organization: Faculty of Medicine, Department of Family Medicine, Hakan Cetinsaya Good Clinical Practise and Research Center, Erciyes University – sequence: 8 givenname: Selma Alime surname: Koru fullname: Koru, Selma Alime organization: IDEAL Biyolojik Urunler ve Ilac Danismanlik Egitimi Ltd. Sti |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/39444050$$D View this record in MEDLINE/PubMed |
| BookMark | eNp9ks2O0zAUhSM0iBnKvAALZAkJsclgx3aSrtBQ8SeNxAbWluNct64Su-OfSn2S2fIsPBlOO8y0COEsbMXfuck99zwvzqyzUBQvCb4ipK3fBYZpjUtcsRLjFtMSPykuKsxxWXNCzo7O58VlCGucV9O0La-eFed0zhjL9xfF3Qfj4DaZrRzAKkAhpn6HnEYwRO_Gzm3kEjX8189xibQZxlI5GaFHUXYDxICS7cEjLUM0domUs72JxtmA-uSnN3EFaOG2pi_JHG1kpkejkLFoBXKIqx1ayKRkMNKiMf8CCqlbg4rhRfFUyyHA5f0-K358-vh98aW8-fb56-L6plS8YrGETjYdyFpT1lY17-YdJ02rCZYaWK_mpKkaTWRd86bO_WKm2gZ6oFRThRVIOiveH-puUjdCr8BGLwex8WaUfiecNOL0xpqVWLqtIIQTXuchzIq39xW8u00QohhNUDAM0oJLQVBSYcxbMucZff0XunbJ29yfoBUmnFHO2CO1zIYIY7XLH1ZTUXHdEsqqafCZuvoHlZ-9wzkreVpwKnhzJDjYH9yQ9uM6BV8dW_LgxZ_QZKA6AMq7EDzoB4RgMYVTHMIpcjjFPpxiEtGDKGymYIB_7P0_qt_rTObj |
| Cites_doi | 10.1016/j.clinthera.2009.04.010 10.1200/JCO.22.02699 10.1007/s40265-016-0581-4 10.1016/j.yrtph.2012.08.001 10.1002/prp2.1253 10.1002/cpdd.1342 10.2165/00003495-200868070-00002 |
| ContentType | Journal Article |
| Copyright | The Author(s) 2024 2024. The Author(s). COPYRIGHT 2024 BioMed Central Ltd. 2024. This work is licensed under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. The Author(s) 2024 2024 |
| Copyright_xml | – notice: The Author(s) 2024 – notice: 2024. The Author(s). – notice: COPYRIGHT 2024 BioMed Central Ltd. – notice: 2024. This work is licensed under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: The Author(s) 2024 2024 |
| DBID | C6C AAYXX CITATION CGR CUY CVF ECM EIF NPM 3V. 7U7 7X7 7XB 88E 8AO 8FI 8FJ 8FK ABUWG AFKRA AZQEC BENPR C1K CCPQU COVID DWQXO FYUFA GHDGH K9. M0S M1P PHGZM PHGZT PIMPY PJZUB PKEHL PPXIY PQEST PQQKQ PQUKI PRINS 7X8 5PM |
| DOI | 10.1186/s40360-024-00803-0 |
| DatabaseName | Springer Nature OA Free Journals CrossRef Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed ProQuest Central (Corporate) Toxicology Abstracts Health & Medical Collection ProQuest Central (purchase pre-March 2016) Medical Database (Alumni Edition) ProQuest Pharma Collection Hospital Premium Collection Hospital Premium Collection (Alumni Edition) ProQuest Central (Alumni) (purchase pre-March 2016) ProQuest Central (Alumni) ProQuest Central UK/Ireland ProQuest Central Essentials ProQuest Central Environmental Sciences and Pollution Management ProQuest One Coronavirus Research Database ProQuest Central Health Research Premium Collection Health Research Premium Collection (Alumni) ProQuest Health & Medical Complete (Alumni) ProQuest Health & Medical Collection Medical Database ProQuest Central Premium ProQuest One Academic (New) Publicly Available Content Database ProQuest Health & Medical Research Collection ProQuest One Academic Middle East (New) ProQuest One Health & Nursing ProQuest One Academic Eastern Edition (DO NOT USE) ProQuest One Academic ProQuest One Academic UKI Edition ProQuest Central China MEDLINE - Academic PubMed Central (Full Participant titles) |
| DatabaseTitle | CrossRef MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) Publicly Available Content Database ProQuest One Academic Middle East (New) ProQuest Central Essentials ProQuest Health & Medical Complete (Alumni) ProQuest Central (Alumni Edition) ProQuest One Community College ProQuest One Health & Nursing ProQuest Pharma Collection ProQuest Central China Environmental Sciences and Pollution Management ProQuest Central ProQuest Health & Medical Research Collection Health Research Premium Collection Health and Medicine Complete (Alumni Edition) ProQuest Central Korea Health & Medical Research Collection ProQuest Central (New) ProQuest Medical Library (Alumni) Toxicology Abstracts ProQuest One Academic Eastern Edition Coronavirus Research Database ProQuest Hospital Collection Health Research Premium Collection (Alumni) ProQuest Hospital Collection (Alumni) ProQuest Health & Medical Complete ProQuest Medical Library ProQuest One Academic UKI Edition ProQuest One Academic ProQuest One Academic (New) ProQuest Central (Alumni) MEDLINE - Academic |
| DatabaseTitleList | Publicly Available Content Database MEDLINE - Academic MEDLINE |
| Database_xml | – sequence: 1 dbid: C6C name: Springer Nature OA Free Journals url: http://www.springeropen.com/ sourceTypes: Publisher – sequence: 2 dbid: NPM name: PubMed url: https://proxy.k.utb.cz/login?url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 3 dbid: EIF name: MEDLINE url: https://proxy.k.utb.cz/login?url=https://www.webofscience.com/wos/medline/basic-search sourceTypes: Index Database – sequence: 4 dbid: BENPR name: ProQuest Central url: http://www.proquest.com/pqcentral?accountid=15518 sourceTypes: Aggregation Database |
| DeliveryMethod | fulltext_linktorsrc |
| Discipline | Pharmacy, Therapeutics, & Pharmacology |
| EISSN | 2050-6511 |
| ExternalDocumentID | PMC11515640 A813420360 39444050 10_1186_s40360_024_00803_0 |
| Genre | Equivalence Trial Randomized Controlled Trial Journal Article |
| GrantInformation_xml | – fundername: ILKO pharmaceuticals |
| GroupedDBID | 0R~ 53G 5VS 7X7 88E 8AO 8FI 8FJ AAFWJ AAJSJ AASML ABUWG ACGFS ACIHN ADBBV ADRAZ ADUKV AEAQA AENEX AFKRA AFPKN AHBYD AHMBA AHYZX ALMA_UNASSIGNED_HOLDINGS AMKLP AOIJS ASPBG BCNDV BENPR BFQNJ BMC BPHCQ BVXVI C6C CCPQU DIK EBD EBLON EBS EMB EMOBN FYUFA GROUPED_DOAJ GX1 HH5 HMCUK HYE IAO IHR IHW INH INR ITC KQ8 M1P M48 MK0 M~E OK1 PGMZT PHGZM PHGZT PIMPY PJZUB PPXIY PQQKQ PROAC PSQYO PUEGO RBZ RNS ROL RPM RSV SOJ SV3 UKHRP W2D AAYXX CITATION ALIPV CGR CUY CVF ECM EIF NPM PMFND 3V. 7U7 7XB 8FK AZQEC C1K COVID DWQXO K9. PKEHL PQEST PQUKI PRINS 7X8 5PM |
| ID | FETCH-LOGICAL-c524t-eba7bea6f348265b9b5178f10afe4dc91727f1a6657605004c87ede33f3c0cea3 |
| IEDL.DBID | M48 |
| ISSN | 2050-6511 |
| IngestDate | Tue Sep 30 17:07:17 EDT 2025 Fri Sep 05 11:57:49 EDT 2025 Fri Jul 25 10:56:08 EDT 2025 Tue Jun 17 22:02:37 EDT 2025 Tue Jun 10 21:00:44 EDT 2025 Thu May 22 21:24:26 EDT 2025 Mon Jul 21 05:28:53 EDT 2025 Wed Oct 01 03:13:00 EDT 2025 Sat Sep 06 07:27:25 EDT 2025 |
| IsDoiOpenAccess | true |
| IsOpenAccess | true |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 1 |
| Keywords | Bioequivalence study Eltrombopag Bioavailability Pharmacokinetic |
| Language | English |
| License | 2024. The Author(s). Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/. |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c524t-eba7bea6f348265b9b5178f10afe4dc91727f1a6657605004c87ede33f3c0cea3 |
| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 |
| OpenAccessLink | http://journals.scholarsportal.info/openUrl.xqy?doi=10.1186/s40360-024-00803-0 |
| PMID | 39444050 |
| PQID | 3201543544 |
| PQPubID | 2028884 |
| ParticipantIDs | pubmedcentral_primary_oai_pubmedcentral_nih_gov_11515640 proquest_miscellaneous_3120058195 proquest_journals_3201543544 gale_infotracmisc_A813420360 gale_infotracacademiconefile_A813420360 gale_healthsolutions_A813420360 pubmed_primary_39444050 crossref_primary_10_1186_s40360_024_00803_0 springer_journals_10_1186_s40360_024_00803_0 |
| ProviderPackageCode | CITATION AAYXX |
| PublicationCentury | 2000 |
| PublicationDate | 2024-10-23 |
| PublicationDateYYYYMMDD | 2024-10-23 |
| PublicationDate_xml | – month: 10 year: 2024 text: 2024-10-23 day: 23 |
| PublicationDecade | 2020 |
| PublicationPlace | London |
| PublicationPlace_xml | – name: London – name: England |
| PublicationTitle | BMC pharmacology & toxicology |
| PublicationTitleAbbrev | BMC Pharmacol Toxicol |
| PublicationTitleAlternate | BMC Pharmacol Toxicol |
| PublicationYear | 2024 |
| Publisher | BioMed Central BioMed Central Ltd |
| Publisher_xml | – name: BioMed Central – name: BioMed Central Ltd |
| References | 803_CR3 R Stasi (803_CR4) 2008; 68 803_CR5 803_CR7 803_CR9 A Inal (803_CR10) 2024; 12 CB Burness (803_CR8) 2016; 76 T Grabowski (803_CR16) 2012; 64 803_CR14 EN Oliva (803_CR1) 2023; 41 803_CR15 803_CR12 803_CR13 803_CR11 DD Williams (803_CR6) 2009; 31 803_CR2 |
| References_xml | – volume: 31 start-page: 764 issue: 4 year: 2009 ident: 803_CR6 publication-title: Clin Ther doi: 10.1016/j.clinthera.2009.04.010 – volume: 41 start-page: 4486 issue: 28 year: 2023 ident: 803_CR1 publication-title: J Clin Oncol doi: 10.1200/JCO.22.02699 – volume: 76 start-page: 869 year: 2016 ident: 803_CR8 publication-title: Drugs doi: 10.1007/s40265-016-0581-4 – volume: 64 start-page: 233 year: 2012 ident: 803_CR16 publication-title: Regul Toxicol Pharmacol doi: 10.1016/j.yrtph.2012.08.001 – volume: 12 start-page: e1253 issue: 4 year: 2024 ident: 803_CR10 publication-title: Pharmacol Res Perspect doi: 10.1002/prp2.1253 – ident: 803_CR2 – ident: 803_CR3 – ident: 803_CR5 – ident: 803_CR15 – ident: 803_CR9 doi: 10.1002/cpdd.1342 – ident: 803_CR14 – ident: 803_CR12 – ident: 803_CR7 – ident: 803_CR13 – ident: 803_CR11 – volume: 68 start-page: 901 issue: 7 year: 2008 ident: 803_CR4 publication-title: Drugs doi: 10.2165/00003495-200868070-00002 |
| SSID | ssj0000778852 |
| Score | 2.3212876 |
| Snippet | This study aims to determine the bioequivalence of the reference preparation and the test preparation containing eltrombopag when both were given during the... |
| SourceID | pubmedcentral proquest gale pubmed crossref springer |
| SourceType | Open Access Repository Aggregation Database Index Database Publisher |
| StartPage | 80 |
| SubjectTerms | Adult Antigens Area Under Curve Benzoates - administration & dosage Benzoates - blood Benzoates - pharmacokinetics Bioavailability Bioequivalence Biomedical and Life Sciences Biomedicine Blood Body temperature Clinical medicine Clinical trials COVID-19 COVID-19 Drug Treatment Cross-Over Studies Drug dosages Eltrombopag Fasting Generic products Healthy Volunteers Hepatitis Hospitalization Humans Hydrazines - administration & dosage Hydrazines - blood Hydrazines - pharmacokinetics Male Males Medical examination Pandemics Pharmacokinetics Pharmacology/Toxicology Plasma Pyrazoles - administration & dosage Pyrazoles - blood Pyrazoles - pharmacokinetics Rivaroxaban Samples Tablets - pharmacokinetics Tandem Mass Spectrometry - methods Therapeutic Equivalency White People Young Adult |
| SummonAdditionalLinks | – databaseName: Health & Medical Collection dbid: 7X7 link: http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwfV1fj9MwDI_geOEF8Z_BAUZCxwOLrm3SNH1Cx8TphAS6hztpb1WapEelW7tbu4d9ET4vdtttdBI8x52S2Y4d2z-bsY9OBUlkUsHTJFUc7bXiudGKJ86JyPkoSiWBk3_8VBfX8vs8ng8Bt2Yoq9zeid1F7WpLMfJTEZG1F7GUX5Z3nKZGUXZ1GKFxnz0I0VUhqU7myS7GEiT4wIujLVZGq9NG4o0dcDRMnHwlwYORPTq8lf8yS4clkwd5084cnT9mjwY_Es56xj9h93z1lJ1c9o2oN1O42uOqmimcwOW-RfXmGfv9taz93bpEMSPNhq7JLNQF-Nt2VS-o1OQGkhgWN1CUtwtua3RJHbSEs2obIODZCgrTUM004Iva9YVf0IMeAZ1KmBHCj4cpLClMvSgtlBX0qMsNzAzNWkPJhAXuAJp1TuGg5jm7Pv92Nbvgw4QGbuNIttznJsm9UQW1yFFxnuZxmOgiDEzhpbMpeUdFaCi7g88m1EerE--8EIWwgfVGvGBHVV35VwykMTZ2OtA-l_imjY13WheCBu0pFQg3YZ-3fMqWfSOOrHvAaJX1XM2Qq1nH1SyYsPfEyqw_1k6LszMdCkm5V6T41FGQHiNHrRngCLgb6og1ojweUaL-2fHyVlyyQf-bbC-tE_Zht0xfUk1b5es10oQU0aM85oS97KVrdzKCK6MrjT-uR3K3I6Cu4OOVqvzVdQcPyUVVEj-dbkV0v69__2Ov_3-MN-xhRFqDVjsSx-yoXa39W3TH2vxdp3N_AIJwM5U priority: 102 providerName: ProQuest – databaseName: Springer Nature OA Free Journals dbid: C6C link: http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwlV3NbtQwELZQuXBB_LNQYJBQObAWSew4zrFEVBUSqIdW6i1yYqdEapKyyR72SbjyLDwZM0k226zgwNnjyM7MeGY8840Ze2eVFwUmFjyOYsXRXiueGa14ZK0IrAuCWBI4-es3dXohv1yGl2ObHMLC3M7f-1p9bCUesR5HS8LJuREcw_O7IR68VL6XqGS6T_EiDObCYIuL-evUme3ZP4FvmaD98si9HGlvek4esPujzwjHA5MfsjuufsSOzoam05slnO8wVO0SjuBs145685j9_FQ27se6RJEiLYa-oSw0BbjrbtVUVFZyBVH4-1d1BUV5XfG8Qf_TQkegqq4FQpmtoDAtFUgDhs92qPKCAeEI6EFCQnA-7sdwQ3fSVZlDWcMAsdxAYuhhNRRDqHAJ0K4zuvtpn7CLk8_nySkfn2PgeRjIjrvMRJkzqqB-OCrM4iz0I134nimctHlMrlDhG0rlYIyEypfryFknRCFyL3dGPGUHdVO75wykMXlotaddJjGADY2zWheCXtVTyhN2wT5sGZXeDF030j5a0Sod2JoiW9Oeram3YG-Il-mwrUll02PtC0mJVqR431OQ0iJLczNiD3A11P5qRnk4o0Rly-fDW3lJR2VvUxGQIypCKRfs7TRMM6mArXbNGml8ur6jpOWCPRvEa9oZYZPRb8aP65ngTQTUAnw-Upff-1bgPvmjSuLU5VZGd-v69x978X_kL9m9gNQITXYgDtlBt1q7V-iLddnrXgn_AHGGLaQ priority: 102 providerName: Springer Nature |
| Title | Bioequivalence study of eltrombopag 75 mg film-coated tablets under fasting conditions during the Covid-19 pandemic in healthy Caucasian male subjects |
| URI | https://link.springer.com/article/10.1186/s40360-024-00803-0 https://www.ncbi.nlm.nih.gov/pubmed/39444050 https://www.proquest.com/docview/3201543544 https://www.proquest.com/docview/3120058195 https://pubmed.ncbi.nlm.nih.gov/PMC11515640 |
| Volume | 25 |
| hasFullText | 1 |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| journalDatabaseRights | – providerCode: PRVFSB databaseName: Free Full-Text Journals in Chemistry customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: HH5 dateStart: 20120101 isFulltext: true titleUrlDefault: http://abc-chemistry.org/ providerName: ABC ChemistRy – providerCode: PRVADU databaseName: BioMed Central Open Access Free customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: RBZ dateStart: 20010101 isFulltext: true titleUrlDefault: https://www.biomedcentral.com/search/ providerName: BioMedCentral – providerCode: PRVAFT databaseName: Open Access Digital Library customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: KQ8 dateStart: 20120101 isFulltext: true titleUrlDefault: http://grweb.coalliance.org/oadl/oadl.html providerName: Colorado Alliance of Research Libraries – providerCode: PRVAON databaseName: DOAJ Directory of Open Access Journals customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: DOA dateStart: 20120101 isFulltext: true titleUrlDefault: https://www.doaj.org/ providerName: Directory of Open Access Journals – providerCode: PRVBFR databaseName: Free Medical Journals customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: DIK dateStart: 20120101 isFulltext: true titleUrlDefault: http://www.freemedicaljournals.com providerName: Flying Publisher – providerCode: PRVFQY databaseName: GFMER Free Medical Journals customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: GX1 dateStart: 0 isFulltext: true titleUrlDefault: http://www.gfmer.ch/Medical_journals/Free_medical.php providerName: Geneva Foundation for Medical Education and Research – providerCode: PRVHPJ databaseName: ROAD: Directory of Open Access Scholarly Resources customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: M~E dateStart: 20120101 isFulltext: true titleUrlDefault: https://road.issn.org providerName: ISSN International Centre – providerCode: PRVAQN databaseName: PubMed Central customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: RPM dateStart: 20120101 isFulltext: true titleUrlDefault: https://www.ncbi.nlm.nih.gov/pmc/ providerName: National Library of Medicine – providerCode: PRVPQU databaseName: Health & Medical Collection customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: 7X7 dateStart: 20150101 isFulltext: true titleUrlDefault: https://search.proquest.com/healthcomplete providerName: ProQuest – providerCode: PRVPQU databaseName: ProQuest Central customDbUrl: http://www.proquest.com/pqcentral?accountid=15518 eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: BENPR dateStart: 20150101 isFulltext: true titleUrlDefault: https://www.proquest.com/central providerName: ProQuest – providerCode: PRVFZP databaseName: Scholars Portal Journals: Open Access customDbUrl: eissn: 2050-6511 dateEnd: 20250630 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: M48 dateStart: 20120901 isFulltext: true titleUrlDefault: http://journals.scholarsportal.info providerName: Scholars Portal – providerCode: PRVAVX databaseName: Springer Nature HAS Fully OA customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: AAJSJ dateStart: 20121201 isFulltext: true titleUrlDefault: https://www.springernature.com providerName: Springer Nature – providerCode: PRVAVX databaseName: Springer Nature OA Free Journals customDbUrl: eissn: 2050-6511 dateEnd: 99991231 omitProxy: true ssIdentifier: ssj0000778852 issn: 2050-6511 databaseCode: C6C dateStart: 20121201 isFulltext: true titleUrlDefault: http://www.springeropen.com/ providerName: Springer Nature |
| link | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwdV3NattAEF7SBEoupf9Vm7pTKOmh3lbSSivpUIpjEoIhwbQx-CZW0ioV2FJiyVA_Sa99lj5ZZyTLrkxyEmhnYaX5Zmdmd34Y-5BI07NVIHjgBZKjvpY8Ur7kXpIIO9G2HTiUnHxxKc8nzmjqTvdY2-5o_QPLO1076ic1Wcw-_7pdfUOB_1oLvC-_lA5uwyZHbcPJABIcXfgD1Ew2ofxibe7XO7OHDp9rt7kzd049ZA8pVxTtGLOjqnY37P801m405c6Vaq2pzh6zR2sTEwYNJp6wPZ0_Zcfjpkb1qg9X25Srsg_HMN5Wr149Y79PskLfLjNEIAk91PVnoUhBz6pFMacolGvw3L9_5teQZrM5jws0VxOoKAerKoGS0haQqpLiqQG97aQJCoMmIRLQ4IQhZf9xK4AbOsKeZzFkOTQZmSsYKurDhqiFOS4BymVER0XlczY5O70anvN19wYeu7ZTcR0pL9JKplQ-R7pRELmW56eWqVLtJHFAllNqKbr5QZcKZTX2PZ1oIVIRm7FW4gXbz4tcv2LgKBW7iW_6OkLG2K7Sie-ngprwSWmKxGCfWkaFN02RjrB2bnwZNhwOkcNhzeHQNNg74mXYfNZGwsOBbwmH7mWR4mNNQahDlsZqnaqAq6FqWR3Kow4lymbcHW7xErbQDoVNdqtwHcdg7zfDNJPi3XJdLJHGotM-uuM02MsGXpsva-FpML8DvA0BVQzvjuTZz7pyuEXmq3Rwar_F6HZd9_-x1_eu4Q07tEl4UJnb4ojtV4ulfotWWhX12ANv6vXYwWAw-jHC58np5fg7vh3KYa8--ejVwvkPEB89tw |
| linkProvider | Scholars Portal |
| linkToHtml | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwtV1Lb9NAEF6VcoAL4k2g0EGCciCr2t7164BQCVQpfaiHVMrNXXvXxVJjp7EjlD_Cz-A3MmPHCY4Et553vNr1PHdnvlnG3mnP8h0VCh76ocfRX3s8VoHHfa2Fo43jhJLAyadn3vBCfh-74y32u8XCUFllaxNrQ62LhO7I94VD3l64Un6e3nB6NYqyq-0TGo1YHJvFTzyylZ-OviJ_3zvO4bfRYMiXrwrwxHVkxU2s_NgoL6W2Lp4bh7Fr-0FqWyo1UichefTUVpSRwFAfZSgJfKONEKlIrMQogfPeYXelsCT16vfH_upOx_LxQOk6LTYn8PZLiR7C4ugIOcVmglsd_7fpBf5yg5slmht52tr9HT5kD5ZxKxw0gvaIbZn8Mds7bxpfL_owWuO4yj7swfm6JfbiCfv1JSvMzTxDsSZLAnVTWyhSMNfVrJhQacsV-C5MriDNric8KTAE1lARrqsqgYBuM0hVSTXagCd43RSaQQOyBAxiYUCIQm6HMKVr8UmWQJZDg_JcwEDR226oCTDBFUA5j-n6qXzKLm6Fd8_Ydl7k5gUDqVTi6sAKTCzxDO0qo4MgFfSwn-dZQvfYx5ZP0bRp_BHVB6bAixquRsjVqOZqZPXYLrEyara1shrRQWALSblepPhQU5DdQI4magl_wNVQB64O5U6HEvU96Q634hIt7U0ZrbWjx96uhulLqqHLTTFHGptuEClv2mPPG-la7Yzg0Ri64-RBR-5WBNSFvDuSZz_qbuQ2hcSexE_7rYiu1_XvP_by_9vYZfeGo9OT6OTo7PgVu--QBmHE4Igdtl3N5uY1hoJV_KbWP2CXt63wfwAYjnDx |
| linkToPdf | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwlV3NbtQwELZQKyEuiPK7UOggoXJgrSZx4jjHZWFVFqhWopV6i5zYaSN1k2WTPeyT9Mqz8GTMJPvTrODA2ePIzsx4ZjzzjRl7Z6QTejoSPAojydFeS55oJXlojPCM9bzIJ3Dy9zN5euGPL4PLOyj-ptp9nZJsMQ3UpamoT2Yma1VcyZPKx4PX4WhfOLk8gmPQvq-CSGL4tT8YjH-MN_csTohBXuCt8TJ_ndyxSbsn8x3TtFs2uZM7bUzS6BF7uPIlYdAy_4Dds8Vjdjxpm1Ev-3C-xVZVfTiGybZN9fIJu_2Yl_bnIkdRI-2GptEslBnYm3peTqnc5ArC4Pev6RVk-c2UpyX6pQZqAlvVFRD6bA6ZrqhwGvD_mbb6C1rkI6BnCUOC-XE3ghndVU_zFPICWujlEoaaHlxD8YQpLgGqRUJ3QtVTdjH6fD485atnGngaeH7NbaLDxGqZUZ8cGSRRErihylxHZ9Y3aUQuUuZqSvFg7IRKmarQGitEJlIntVo8Y3tFWdgXDHyt08AoR9nEx8A20NYolQl6bU9KR5ge-7BmVDxru3HETRSjZNyyNUa2xg1bY6fHjoiXcbutjSrHA-UKnxKwSPG-oSBlRpameoVJwNVQW6wO5WGHEpUw7Q6v5SVeHQJVLDxyUEXg-z32djNMM6mwrbDlAmlcutajZGaPPW_Fa7MzwiyjP40fVx3B2xBQa_DuSJFfNy3CXfJTpY9T-2sZ3a7r33_s5f-RH7H7k0-j-NuXs6-v2AOPNAqtuicO2V49X9jX6K7VyZuVRv4BI5c6Tw |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Bioequivalence+study+of+eltrombopag+75%C2%A0mg+film-coated+tablets+under+fasting+conditions+during+the+Covid-19+pandemic+in+healthy+Caucasian+male+subjects&rft.jtitle=BMC+pharmacology+%26+toxicology&rft.au=Inal%2C+Ahmet&rft.au=Sezer%2C+Zafer&rft.au=Pinarbasli%2C+Onur&rft.au=Bulut%2C+Burcu&rft.date=2024-10-23&rft.eissn=2050-6511&rft.volume=25&rft.issue=1&rft.spage=80&rft_id=info:doi/10.1186%2Fs40360-024-00803-0&rft_id=info%3Apmid%2F39444050&rft.externalDocID=39444050 |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=2050-6511&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=2050-6511&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=2050-6511&client=summon |