Atrial Fibrillation (AF)NCT07396519
Bioequivalence Study of Dronedarone Hydrochloride Tablets
A study testing Dronedarone Hydrochloride Tablets and MULTAQ® (Dronedarone Hydrochloride Tablets) in people with Atrial Fibrillation (AF), run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
The test formulation of Dronedarone Hydrochloride Tablets (400 mg) is bioequivalent to the reference formulation (MULTAQ®) in healthy Chinese subjects under fed conditions. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Dronedarone Hydrochloride Tablets and MULTAQ® (Dronedarone Hydrochloride Tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2022to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 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.
- 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.
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- 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.
- 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.
- Any other condition considered by the investigator as unsuitable for participation or voluntary withdrawal.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangxi Cancer Hospital ＆ Institute (The Second Affiliated Hospital of Nanchang Medical College)
Nanchang, Jiangxi, 330029
About this study
The test formulation of Dronedarone Hydrochloride Tablets (400 mg) is bioequivalent to the reference formulation (MULTAQ®) in healthy Chinese subjects under fed conditions.
Read the detailed description
This is a single-center, randomized, open-label, single-dose, two-formulation, two-sequence 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 fed conditions. A planned total of 48 eligible subjects will 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)
- Being tested
- Dronedarone Hydrochloride Tablets, MULTAQ® (Dronedarone Hydrochloride Tablets)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronedarone Hydrochloride TabletsDrug
Test Product. Manufacturer: Shandong New Time Pharmaceutical Co., Ltd. Dosage Form/Strength: 400 mg tablet Administration: Single oral dose of 400 mg (1 tablet).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: MULTAQ® (Dronedarone Hydrochloride Tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 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
Measured: 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
Measured: 72 hours post-dose in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start14 Nov 2022
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396519
- Sponsor's protocol ID
- NTP-JNDL-T-BEO1
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Dronedarone Hydrochloride Tablets
- ClinicalTrials.gov ID
- NCT07396519
- Acronym / sponsor ID
- NTP-JNDL-T-BEO1
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The test formulation of Dronedarone Hydrochloride Tablets (400 mg) is bioequivalent to the reference formulation (MULTAQ®) in healthy Chinese subjects under fed conditions.
Detailed description
This is a single-center, randomized, open-label, single-dose, two-formulation, two-sequence 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 fed conditions. A planned total of 48 eligible subjects will 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dronedarone Hydrochloride Tablets | Experimental | Drug: Dronedarone Hydrochloride TabletsHealthy 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. |
| MULTAQ® | Active comparator | Drug: MULTAQ® (Dronedarone Hydrochloride Tablets)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronedarone Hydrochloride TabletsTest Product. Manufacturer: Shandong New Time Pharmaceutical Co., Ltd. Dosage Form/Strength: 400 mg tablet Administration: Single oral dose of 400 mg (1 tablet). | Drug | Dronedarone Hydrochloride Tablets |
| 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). | Drug | MULTAQ® |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 72 hours post-dose in each period
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC) 0-t
Time frame: 72 hours post-dose in each period
plasma concentration-time curve from zero to the time of the last measurable time point t
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 72 hours post-dose in each period
area under the plasma concentration-time curve from zero to infinity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dronedarone Hydrochloride Tablets and MULTAQ® (Dronedarone Hydrochloride Tablets) in people with Atrial Fibrillation (AF), run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 72 hours post-dose in each period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.