Clinical Trial

Bioequivalence Study of Dronedarone Hydrochloride Tablets in Healthy Subjects Under Fasting Conditions

Name: Bioequivalence Study of Dronedarone Hydrochloride Tablets in Healthy Subjects Under Fasting Conditions — clinical trial record (NCT07396506)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Completed

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Summary

The test formulation of Dronedarone Hydrochloride Tablets (400 mg) is bioequivalent to the reference formulation (MULTAQ®) in healthy Chinese subjects under fasting conditions.

Trial Details

NCT Number	NCT07396506
Lead Sponsor	Shandong New Time Pharmaceutical Co., LTD
Conditions	Atrial Fibrillation (AF)
Enrollment	51 participants
Start Date	2023-06-05
Primary Completion	2023-07-10 (estimated)
Study Completion	2023-07-10 (estimated)
Updated on ClinicalTrials.gov	2026-02-09