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
Unknown Phase 1 NCT06876623
Study Description
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.
Study Details
- Registry ID:
- NCT06876623
- Conditions:
- Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects
- Phase:
- Phase 1
- Target Enrollment:
- 88 participants
- Start Date:
- Age Range:
- 18–999 years
- Healthy Volunteers:
- No
Study Locations (1 site)
-
Clinical Trials Center, The Affiliated Hospital of Guizhou Medical University
Guiyang, China
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