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

NCT07396506 | Completed

• 1 other identifier: NTP-JNDL-T-BEO2
• Study Type: interventional
• Target: 51
• 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 fasting 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

  36 days

Study Arms (2)

Dronedarone Hydrochloride Tablets

EXPERIMENTAL

Healthy male subjects will be randomized to one of three treatment sequences (A, B, or C) to receive single oral doses of the Test and Reference formulations under fasting conditions, according to a three-period, partially replicated crossover design with a 10-day washout period between each period.

Drug: Dronedarone Hydrochloride Tablets

MULTAQ®

ACTIVE COMPARATOR

Healthy male subjects will be randomized to one of three treatment sequences (A, B, or C) to receive single oral doses of the Test and Reference formulations under fasting conditions, according to a three-period, partially replicated crossover design with a 10-day washout period between each period.

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 (e.g., intolerance to the standard meal) 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: June 5, 2023
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)