Bioequivalence study of eltrombopag 75 mg film-coated tablets under fasting conditions during the Covid-19 pandemic in healthy Caucasian male subjects.
Adult
Humans
Male
Young Adult
Area Under Curve
Benzoates
/ pharmacokinetics
COVID-19
COVID-19 Drug Treatment
Cross-Over Studies
Fasting
Healthy Volunteers
Hydrazines
/ pharmacokinetics
Pyrazoles
/ pharmacokinetics
Tablets
/ pharmacokinetics
Tandem Mass Spectrometry
/ methods
Therapeutic Equivalency
White People
Bioavailability
Bioequivalence study
Eltrombopag
Pharmacokinetic
Journal
BMC pharmacology & toxicology
ISSN: 2050-6511
Titre abrégé: BMC Pharmacol Toxicol
Pays: England
ID NLM: 101590449
Informations de publication
Date de publication:
23 Oct 2024
23 Oct 2024
Historique:
received:
21
08
2024
accepted:
16
10
2024
medline:
24
10
2024
pubmed:
24
10
2024
entrez:
24
10
2024
Statut:
epublish
Résumé
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
Identifiants
pubmed: 39444050
doi: 10.1186/s40360-024-00803-0
pii: 10.1186/s40360-024-00803-0
doi:
Substances chimiques
Benzoates
0
eltrombopag
S56D65XJ9G
Hydrazines
0
Pyrazoles
0
Tablets
0
Types de publication
Equivalence Trial
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
80Informations de copyright
© 2024. The Author(s).
Références
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