NCT05715658

Pharmacokinetic Study to Evaluate Dabigatran Etexilate in Elderly Subjects

A Study Evaluating the Pharmacokinetics of Dabigatran Etexilate in Adult Healthy Subjects, Elderly Healthy Subjects, and Elderly Patients With Atrial Fibrillation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Dongyang Liu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Nonvalvular Atrial Fibrillation
• Health, Subjective

Interventions

Type	Name	Description
DRUG	Dabigatran etexilate capsule	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.

Timeline

• Start date: 2022-08-15
• Primary completion: 2023-06-30
• Completion: 2023-07-30
• First posted: 2023-02-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: China