Bioequivalence Study of Dronedarone Hydrochloride Tablets

NCT07396519 | Completed

• 1 other identifier: NTP-JNDL-T-BEO1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Evaluation of Peak Plasma Concentration (Cmax)

  72 hours post-dose in each period

• Area under the plasma concentration versus time curve (AUC) 0-t

  plasma concentration-time curve from zero to the time of the last measurable time point t

  72 hours post-dose in each period

• Area under the plasma concentration versus time curve (AUC)0-∞

  area under the plasma concentration-time curve from zero to infinity

  72 hours post-dose in each period

Other Outcomes (2)

• maximum plasma concentration (tmax)

  72 hours post-dose in each period

• Incidence of Treatment-Emergent Adverse Events

  24 days

Study Arms (2)

Dronedarone Hydrochloride Tablets

EXPERIMENTAL

Healthy male subjects will be randomized to receive a single oral dose of the Test and Reference formulations under fed conditions (30 minutes after a high-fat, high-calorie meal), according to a two-period, two-sequence crossover design with a 10-day washout period between periods.

Drug: Dronedarone Hydrochloride Tablets

MULTAQ®

ACTIVE COMPARATOR

Healthy male subjects will be randomized to receive a single oral dose of the Test and Reference formulations under fed conditions (30 minutes after a high-fat, high-calorie meal), according to a two-period, two-sequence crossover design with a 10-day washout period between periods.

Drug: MULTAQ® (Dronedarone Hydrochloride Tablets)

Interventions

Dronedarone Hydrochloride Tablets DRUG

Test Product. Manufacturer: Shandong New Time Pharmaceutical Co., Ltd. Dosage Form/Strength: 400 mg tablet Administration: Single oral dose of 400 mg (1 tablet).

Dronedarone Hydrochloride Tablets

MULTAQ® (Dronedarone Hydrochloride Tablets) DRUG

Reference Product. Manufacturer: Sanofi-Aventis U.S. LLC Dosage Form/Strength: 400 mg tablet Administration: Single oral dose of 400 mg (1 tablet).

MULTAQ®

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male subjects who voluntarily participate and provide written informed consent in accordance with Good Clinical Practice (GCP) guidelines.
• Age ≥ 18 years.
• Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive).
• In good health as determined by comprehensive medical history, physical examination, and laboratory tests.
• Able to comply with the study protocol and scheduled visits.

You may not qualify if:

• Any clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, cardiac ultrasound, or laboratory tests (including hematology, blood biochemistry, urinalysis, virology serology, and coagulation function).
• History of specific allergies (e.g., asthma, urticaria, eczema), allergic constitution (allergy to two or more drugs or substances like milk/pollen), or known hypersensitivity to dronedarone, its components, or related compounds.
• Major trauma or significant blood loss within 3 months prior to screening.
• History of drug abuse within the past 5 years or positive urine drug screen.
• Difficulty with blood sampling, needle phobia, or intolerance to venipuncture.
• Positive alcohol breath test at screening.
• Excessive alcohol consumption (\>14 units per week; 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine) within 3 months prior to screening, or unwillingness to abstain from alcohol during the study.
• Excessive consumption of tea, coffee, or caffeine-containing beverages (\>8 cups per day; 1 cup = 250 mL) within 3 months prior to screening, or consumption of any alcohol, caffeine, or xanthine-rich products (e.g., coffee, strong tea, chocolate, cola, grapefruit) within 48 hours prior to dosing.
• Inability to comply with a standardized diet, including food intolerance (e.g., to the standard meal), lactose intolerance, or dysphagia.
• Smoking ≥5 cigarettes per day within 3 months prior to screening or unwillingness to refrain from smoking during the study.
• Use of any medication (prescription, over-the-counter, herbal, or supplements) within 14 days prior to screening.
• Use of any medication known to interact with dronedarone within 1 month prior to screening, including: QT-prolonging drugs, digoxin, calcium channel blockers, CYP2D6 substrates, potent CYP3A inhibitors, CYP3A inducers, statins, and narrow therapeutic index CYP3A substrates (e.g., dabigatran etexilate, warfarin).
• Vaccination within 1 month prior to screening or planned vaccination during the study.
• Participation in any other clinical trial within 3 months prior to screening.
• Blood donation or significant blood loss (≥400 mL in total) within 3 months prior to screening.

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

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

Nanchang, Jiangxi, 330029, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dronedarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amiodarone; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 9, 2026
• Study Start: November 14, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)