Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters
Conditions
Brief 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.
Interventions
Oral dabigatran etexilate capsules, 150 mg twice a day.
Sponsors
The Affiliated Hospital Of Guizhou Medical University
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion and
Exclusion criteria
for healthy subjects were consistent with bioequivalence studies. Inclusion Criteria: 1. Age 18-89 years; 2. ECG meeting the diagnostic criteria for atrial fibrillation; 3. Provide at least one valid blood sample for SNP testing; 4. no contraindication to anticoagulation, blood counts and coagulation times within normal reference values, and negative urine and stool occult blood; 5. not have had any stroke in the 6 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma drug concentration | 3 day | Blood samples collected 10-16 hours after the previous dose were considered trough plasma levels of dabigatran, and blood samples collected 1-3 hours after the dose were considered peak plasma levels. |
Outcome results
None listed