NCT06876623

Bioequivalence Study of Two Dabigatran Etexilate Mesylate Capsules in Healthy Subjects

A Single-dose, Two-sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Dabigatran Etexilate Mesylate Capsules in Healthy Subjects Under Fasting and Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: The Affiliated Hospital Of Guizhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In recent years, novel oral anticoagulants (NOACs) such as Factor Xa inhibitors and direct thrombin inhibitors (e.g., dabigatran etexilate) have emerged. These agents target a single factor in the coagulation pathway and offer advantages including rapid onset of action, fixed dosing, no requirement for coagulation monitoring, and fewer interactions with food and other drugs. Their efficacy and safety in patients with non-valvular atrial fibrillation (NVAF) have been validated by large-scale clinical trials. The aim of this study was to evaluate the bioequivalence of dabigatran mesylate capsules from two different manufacturers after administration to healthy subjects in fasting and postprandial states and to observe the safety of the test and the reference formulation in healthy subjects.

Conditions

• Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects

Interventions

Type	Name	Description
DRUG	dabigatran etexilate mesylate capsules 150mg	Oral dabigatran etexilate mesylate capsules，150mg Once every seven days，two cycle T drug, two cycles R drug

Timeline

• Start date: 2019-12-10
• Primary completion: 2020-06-12
• Completion: 2020-06-12
• First posted: 2025-03-14
• Last updated: 2025-06-29

Locations

1 site across 1 country: China