Trial intelligence / Profile preview

Bioequivalence of Dronedarone Hydrochloride in healthy subjects

NCT07396519Phase 1Completed

Sponsor
Shandong New Time Pharmaceutical
Start
Nov 2022
Primary completion
Dec 2022
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 Nov 2022; status: completed.

02

Drugs

dronedarone
03

Conditions

Atrial fibrillation (AFib)

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