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Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran
Sponsor: The Affiliated Hospital Of Guizhou Medical University
Summary
According to published studies, the effects of genetic polymorphisms in the ABCB1 and CES1 genes on the blood concentration of dabigatran are controversial, and it is not clear whether dabigatran dosage and dosing intervals need to be adjusted according to genotype or other covariates in Chinese subjects. For these purposes, we will include patient demographics, genetic polymorphisms, and PK data based on a population pharmacokinetic study of dabigatran ester in healthy Chinese subjects to analyze the effect on dabigatran pharmacokinetics. The aim of this study was to develop a population pharmacokinetic model to understand the relationship between dabigatran-related genes and dabigatran plasma levels after a single oral dose in healthy Chinese subjects and patients, and to analyze the effects of genetic variation on the efficacy and safety of dabigatran etexilate.
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2024-05-01
Completion Date
2025-11-25
Last Updated
2024-04-29
Healthy Volunteers
Yes
Interventions
Dabigatran Etexilate 150mg
Oral dabigatran etexilate capsules, 150 mg twice a day.