Bioequivalence Study of Dronedarone Hydrochloride Tablets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
The test formulation of Dronedarone Hydrochloride Tablets (400 mg) is bioequivalent to the reference formulation (MULTAQ®) in healthy Chinese subjects under fed conditions.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: Dronedarone Hydrochloride Tablets (Drug)
MULTAQ®
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.
干预措施: MULTAQ® (Dronedarone Hydrochloride Tablets) (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 72 hours post-dose in each period
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC) 0-t
时间窗: 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-∞
时间窗: 72 hours post-dose in each period
area under the plasma concentration-time curve from zero to infinity
次要结局
未报告次要终点