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Dronedarone Hydrochloride Tablets Bioequivalence Study
NCT07396506Phase 1Completed
- Sponsor
- Shandong New Time Pharmaceutical
- Start
- Jun 2023
- Primary completion
- Jul 2023
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of dronedarone in Atrial fibrillation (AFib) (2 arms), sponsored by Shandong New Time Pharmaceutical. Primary endpoints: Peak Plasma Concentration at 72 hours, Area under the plasma concentration versus time curve 0-t at 72 hours and 1 more. Started Jun 2023; status: completed.
02
Drugs
dronedarone
03
Conditions
Atrial fibrillation (AFib)
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