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NCT06876623
Bioequivalence Study of Two Dabigatran Etexilate Mesylate Capsules in Healthy Subjects
Phase 1 trial testing dabigatran etexilate mesylate capsules 150mg in Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects in 88 participants. Completed in 12 June 2020.
12 June 2020
Quick facts
| Lead sponsor | The Affiliated Hospital Of Guizhou Medical University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 88 |
| Start date | 10 December 2019 |
| Primary completion | 12 June 2020 |
| Estimated completion | 12 June 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- dabigatran etexilate mesylate capsules 150mg — full drug profile →
Conditions studied
- Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects — all drugs for Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects →
Sponsor
The Affiliated Hospital Of Guizhou Medical University
Who can join
18 and older, any sex, with Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06876623
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06876623 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Affiliated Hospital Of Guizhou Medical University
- Last refreshed: 29 June 2025
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