Bioequivalence Study of Two Dabigatran Etexilate Mesylate Capsules in Healthy Subjects
Status:
COMPLETED
Trial end date:
2020-06-12
Target enrollment:
Participant gender:
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.
Phase:
PHASE1
Details
Lead Sponsor:
The Affiliated Hospital Of Guizhou Medical University