NCT07396506

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a single-center, randomized, open-label, single-dose, three-period, partially replicated crossover study designed to evaluate the bioequivalence and safety of a generic formulation versus the reference formulation of Dronedarone Hydrochloride Tablets (400 mg) in healthy Chinese male subjects under fasting conditions. A total of 51 eligible subjects are planned to be enrolled. Venous blood samples are collected for the determination of plasma concentrations of dronedarone and its metabolite N-desbutyl dronedarone. In each study period, samples are taken at pre-dose (0 h) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, and 72 h post-dose.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DRUG	Dronedarone Hydrochloride Tablets	Test Product. Manufacturer: Shandong New Time Pharmaceutical Co., Ltd. Dosage Form/Strength: 400 mg tablet Administration: Single oral dose of 400 mg (1 tablet).
DRUG	MULTAQ® (Dronedarone Hydrochloride Tablets)	Reference Product. Manufacturer: Sanofi-Aventis U.S. LLC Dosage Form/Strength: 400 mg tablet Administration: Single oral dose of 400 mg (1 tablet).

Timeline

• Start date: 2023-06-05
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: China