Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic ParametersNCT06387407
Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran
An observational study of Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters
- What is being tested?
- Dabigatran Etexilate 150mg
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects in the dabigatran etexilate bioequivalence study; patients with nonvalvular atrial fibrillation (NVAF).
Who may be able to join
- Age 18-89 years;
- ECG meeting the diagnostic criteria for atrial fibrillation;
- Provide at least one valid blood sample for SNP testing;
- no contraindication to anticoagulation, blood counts and coagulation times within normal reference values, and negative urine and stool occult blood;
- not have had any stroke in the 6 months prior to enrollment.
Who cannot join
- Cardiac ultrasound suggestive of moderate-to-severe mitral stenosis or after mechanical valve replacement;
- severe hepatic injury or renal insufficiency (estimated glomerular filtration rate [eGFR] <30 mL/(min*1.73m2))
- History of stroke or peripheral arterial embolism during dosing;
- patients at high risk of bleeding, such as history of bleeding, hematologic disorders, other disorders requiring anticoagulant therapy, peptic ulcer and other bleeding, and blood pressure >180/110 mmHg;
- Combination of other serious diseases, such as malignant tumors, severe hepatic and renal insufficiency;
- history of allergy to dabigatran and warfarin.
Trial locations and contacts
1 site in 1 country.
China1 site
The affiliate hosptial of Guizhou medical university
Guiyang, Guizhou, 550000
About this study
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.
- Being tested
- Dabigatran Etexilate 150mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran Etexilate 150mgDrug
Oral dabigatran etexilate capsules, 150 mg twice a day.
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma drug concentration
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.
Measured: 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Aug 2024
- Primary completion10 Jun 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic ParametersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan He, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387407
- Sponsor's protocol ID
- 2024037K
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran
- ClinicalTrials.gov ID
- NCT06387407
- Acronym / sponsor ID
- 2024037K
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects in the dabigatran etexilate bioequivalence study; patients with nonvalvular atrial fibrillation (NVAF).
Key inclusion criteria (5 listed)
- Age 18-89 years;
- ECG meeting the diagnostic criteria for atrial fibrillation;
- Provide at least one valid blood sample for SNP testing;
- no contraindication to anticoagulation, blood counts and coagulation times within normal reference values, and negative urine and stool occult blood;
- not have had any stroke in the 6 months prior to enrollment.
Key exclusion criteria (6 listed)
- Cardiac ultrasound suggestive of moderate-to-severe mitral stenosis or after mechanical valve replacement;
- severe hepatic injury or renal insufficiency (estimated glomerular filtration rate [eGFR] <30 mL/(min*1.73m2))
- History of stroke or peripheral arterial embolism during dosing;
- patients at high risk of bleeding, such as history of bleeding, hematologic disorders, other disorders requiring anticoagulant therapy, peptic ulcer and other bleeding, and blood pressure >180/110 mmHg;
- Combination of other serious diseases, such as malignant tumors, severe hepatic and renal insufficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatran Etexilate 150mgOral dabigatran etexilate capsules, 150 mg twice a day. | Drug | – |
Primary outcome
Plasma drug concentration
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma drug concentration (time frame: 3 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.