NCT06387407

Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: The Affiliated Hospital Of Guizhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters

Interventions

Type	Name	Description
DRUG	Dabigatran Etexilate 150mg	Oral dabigatran etexilate capsules, 150 mg twice a day.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-06-10
• Completion: 2025-11-25
• First posted: 2024-04-29
• Last updated: 2024-04-29