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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Drug: Dronedarone Hydrochloride Tablets; Drug: MULTAQ® (Dronedarone Hydrochloride Tablets)

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Cancer Hospital ＆ Institute (The Second Affiliated Hospital of Nanchang Medical College)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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).
2. History or presence of severe cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immune, dermatological, neurological, or psychiatric diseases. Specific exclusions include: renal insufficiency, heart failure, stroke, permanent atrial fibrillation, second- or third-degree atrioventricular block or sick sinus syndrome, bradycardia (heart rate < 50 bpm), prior amiodarone-associated hepatotoxicity or pulmonary toxicity, hypokalemia, hypomagnesemia, or family history of long QT syndrome.
3. 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.
4. Major trauma or significant blood loss within 3 months prior to screening.
5. History of drug abuse within the past 5 years or positive urine drug screen.
6. Difficulty with blood sampling, needle phobia, or intolerance to venipuncture.
7. Positive alcohol breath test at screening.
8. 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.
9. 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.
10. Inability to comply with a standardized diet (e.g., intolerance to the standard meal) or dysphagia.
11. Smoking ≥5 cigarettes per day within 3 months prior to screening or unwillingness to refrain from smoking during the study.
12. Use of any medication (prescription, over-the-counter, herbal, or supplements) within 14 days prior to screening.
13. 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).
14. Vaccination within 1 month prior to screening or planned vaccination during the study.
15. Participation in any other clinical trial within 3 months prior to screening.
16. Blood donation or significant blood loss (≥400 mL in total) within 3 months prior to screening.
17. Male subjects (or their partners) planning pregnancy from 2 weeks prior to screening until 3 months after study completion, or unwilling to use a medically acceptable non-pharmacological contraceptive method during the study.
18. Any other condition considered by the investigator as unsuitable for participation or voluntary withdrawal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dronedarone Hydrochloride Tablets; 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; Test Product. Manufacturer: Shandong New Time Pharmaceutical Co., Ltd. Dosage Form/Strength: 400 mg tablet Administration: Single oral dose of 400 mg (1 tablet).
Active Comparator: MULTAQ®; 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); Reference Product. Manufacturer: Sanofi-Aventis U.S. LLC Dosage Form/Strength: 400 mg tablet Administration: Single oral dose of 400 mg (1 tablet).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum plasma concentration (Tmax)	time to reach the maximum plasma concentration after drug administration (Tmax)	72 hours post-dose in each period
Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	36 days

Collaborators and Investigators

• Sponsor: Shandong New Time Pharmaceutical Co., LTD

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amiodarone; Benzofurans; Dronedarone
• Other Study ID Numbers: NTP-JNDL-T-BEO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No