UnknownNot Applicable

Pharmacokinetic Study to Evaluate Dabigatran Etexilate in Elderly Subjects

China36 participantsStarted 2022-08-15

Plain-language summary

This study intends to collect blood samples of adult healthy subjects, elderly healthy subjects and elderly patients with atrial fibrillation after taking dabigatran etexilate for pharmacokinetics and other studies, aiming to reveal the effect of dabigatran etexilate in Chinese elderly population. Pharmacokinetic profile and biomarker concentration levels; fecal samples were collected for gut microbiota studies to further explore potential mechanisms. The results of the study may provide reference for the precision medicine of dabigatran etexilate and other drugs in the elderly population or the development of new clinical drugs.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. With full capacity for civil conduct, the age of adult healthy subjects is ≥18 years old and ≤30 years old; elderly healthy subjects ≥ 75 years old; elderly patients with atrial fibrillation are ≥75 years old.
. Male weight ≥ 50 kg, female weight ≥ 45 kg; body mass index (BMI) within the range of 19.0\~27.0 (including upper and lower limits), body mass index (BMI) = weight (kg) / height 2 (m2).
. Creatinine clearance rate (CRCL): calculated by Cock Croft-Gault equation, adult healthy subjects should have CRCL≥90mL/min; elderly healthy subjects should have CRCL≥60mL/min; elderly patients with atrial fibrillation should have CRCL≥30mL/min.
. Elderly patients with atrial fibrillation should have meet the diagnostic criteria for non-valvular atrial fibrillation.
. Elderly patients with atrial fibrillation are taking Dabigatran etexilate for routine treatment.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Concentration in plasma of dabigatran on the first day before administration

Timeframe: on the first 1 day before administration

Concentration in plasma of dabigatran on the 2, 6, 10, and 24 hours after administration

Timeframe: on the 2, 6, 10, and 24 hours after administration

Species of intestinal flora

Timeframe: on the first 1 day before administration

Trial details

NCT IDNCT05715658

SponsorDongyang Liu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

Contact for this trial

Dongyang Liu

(86)010-82266658 liudongyang@vip.sina.com

View on ClinicalTrials.gov More Nonvalvular Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. With full capacity for civil conduct, the age of adult healthy subjects is ≥18 years old and ≤30 years old; elderly healthy subjects ≥ 75 years old; elderly patients with atrial fibrillation are ≥75 years old.
. Male weight ≥ 50 kg, female weight ≥ 45 kg; body mass index (BMI) within the range of 19.0\~27.0 (including upper and lower limits), body mass index (BMI) = weight (kg) / height 2 (m2).
. Creatinine clearance rate (CRCL): calculated by Cock Croft-Gault equation, adult healthy subjects should have CRCL≥90mL/min; elderly healthy subjects should have CRCL≥60mL/min; elderly patients with atrial fibrillation should have CRCL≥30mL/min.
. Elderly patients with atrial fibrillation should have meet the diagnostic criteria for non-valvular atrial fibrillation.
. Elderly patients with atrial fibrillation are taking Dabigatran etexilate for routine treatment.

Exclusion criteria

What they're measuring

Concentration in plasma of dabigatran on the first day before administration

Timeframe: on the first 1 day before administration

Concentration in plasma of dabigatran on the 2, 6, 10, and 24 hours after administration

Timeframe: on the 2, 6, 10, and 24 hours after administration

Species of intestinal flora

Timeframe: on the first 1 day before administration