Pharmacokinetic Study to Evaluate Dabigatran Etexilate in Elderly Subjects

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study is a single-center, open-label clinical study, with adult healthy subjects, elderly healthy subjects and elderly patients with atrial fibrillation as the research subjects. Adult healthy subjects and elderly healthy subjects only take one 110 mg dabigatran etexilate capsule (low-dose specification in the instruction manual) orally. Elderly patients with atrial fibrillation take dabigatran etexilate according to routine medical treatment. Blood samples at 0 h(before dosing), 2 h, 6 h, 10 h and 24 h after dosing, and additional stool samples were collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05715658
Study type	Interventional
Source	Peking University Third Hospital
Contact	Dongyang Liu
Phone	(86)010-82266658
Email	liudongyang@vip.sina.com
Status	Recruiting
Phase	N/A
Start date	August 15, 2022
Completion date	July 30, 2023

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