Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06387407

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

View on ClinicalTrials.gov

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

DRUG

Dabigatran Etexilate 150mg

Oral dabigatran etexilate capsules, 150 mg twice a day.