Generic heart drug shows promise in early comparison study

NCT ID NCT07396519

Completed Knowledge-focused Sponsor: Shandong New Time Pharmaceutical Co., LTD Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a generic version of dronedarone hydrochloride (400 mg tablets) works the same as the brand-name drug MULTAQ in 48 healthy Chinese adults. Participants took a single dose under fed conditions, and researchers measured drug levels in the blood to check for bioequivalence. The goal was to see if the generic can be a safe, affordable alternative for people with atrial fibrillation.

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 (generic version of MULTAQ)
What this could lead to: If successful, this could help confirm that a lower-cost generic version of dronedarone is as effective as the brand-name drug for treating atrial fibrillation.
What could go wrong: This is a small, early-stage bioequivalence study in healthy volunteers, not patients. It does not test whether the drug actually treats atrial fibrillation or improves outcomes.

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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