Generic heart drug shows promise in small study

NCT ID NCT07396506

Completed Disease control Sponsor: Shandong New Time Pharmaceutical Co., LTD Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a generic version of dronedarone hydrochloride tablets works the same as the brand-name drug MULTAQ in healthy adults. Fifty-one healthy male volunteers took a single dose of either the generic or brand drug under fasting conditions. The results showed the generic was bioequivalent, meaning it releases the same amount of drug into the bloodstream.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Dronedarone hydrochloride tablets (400 mg)
What this could lead to: If successful, this could provide a more affordable generic version of dronedarone for managing atrial fibrillation.
What could go wrong: This was a small, early-stage bioequivalence study in healthy volunteers, not patients. It does not test safety or effectiveness for treating atrial fibrillation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ATRIAL FIBRILLATION (AF)

Contacts and locations

Locations

Jiangxi Cancer Hospital ＆ Institute (The Second Affiliated Hospital of Nanchang Medical College)

Nanchang, Jiangxi, 330029, China

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