Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Participants.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Plasma Maximum concentration (Cmax)
研究概览
简要总结
Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine hydrochloride Enteric-coated Tablets in Healthy Participants.The study is composed of 2 parts. Part 1 is a bioequivalence study with administration 1.5 hours after a high-fat meal, using a randomized, open-label, single-dose, four-period fully replicated design. Part 2 is a food effect study using a single-center, open-label, single-dose, two-period crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 ~65 years (inclusive), male or female;
- •Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19.0 ~ 28.0 kg/m2 (inclusive);
- •Participants with normal results or abnormal results without clinical significance in medical history, vital signs, physical examination, laboratory tests (including hematology, blood biochemistry, urinalysis, coagulation function, and related tests), chest X-ray, and other examinations.
- •Participants and their partners must use effective non-hormonal contraceptive measures (e.g., condoms, inert intrauterine devices, etc.) from 2 weeks before screening until 6 months after the end of the study, unless they have already undergone permanent sterilization (e.g., bilateral tubal ligation, vasectomy, etc.). Participants must also refrain from donating sperm or eggs;
- •Participants who voluntarily sign the informed consent form and are willing to comply with the protocol to complete the study.
排除标准
- •Participants with a history of allergic constitution (allergic to two or more drugs, foods, or pollens);
- •Participants with psychiatric disorders, hepatic or renal dysfunction, gastrointestinal disorders, neurological disorders, or other systemic diseases;
- •Participants with orthostatic hypotension (a decrease in systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg upon standing compared to the supine position);
- •Participants with a QTcF interval exceeding the upper limit of normal (males >450 ms or females >470 ms) on 12-lead ECG, or clinically significant abnormalities on a ECG as judged by the investigator, or a history of arrhythmia, syncope associated with arrhythmia, use of a cardiac pacemaker, or other cardiac conditions. Note: Cardiac conditions include, but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, atrial premature beats, ventricular premature beats, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; personal or family history of long QT syndrome (LQTS); or family history of sudden cardiac death;
- •Heavy smokers or heavy drinkers (consumption of 14 units of alcohol per week within 4 weeks prior to screening: 1 unit = 285 mL beer, or 25 mL spirits, or 150 mL wine; smoking ≥5 cigarettes per day) or those with a history of other substance or drug abuse within the past year;
- •Participants with a positive alcohol breath test or positive urine drug screen at screening;
- •Participants with blood donation or blood loss exceeding 200 mL within 8 weeks prior to screening;
- •Participants who have participated in another clinical trial of an investigational drug within 3 months prior to screening;
- •Participants who habitually consumed excessive caffeinated beverages or foods within 4 weeks prior to screening (e.g., coffee, tea, chocolate, cola, energy drinks) with a daily caffeine intake exceeding 6 units. (1 caffeine unit = 1 cup of coffee [177.4 mL] = 2 cans of cola [354.9 mL] = 1 cup of tea [354.9 mL] = 1/2 can of energy drink = 85 g of chocolate);
- •Participants who used strong or moderate inhibitors of the drug-metabolizing enzyme (CYP2D6) within 4 weeks prior to screening
- •Participants who habitually consumed dragon fruit, mango, grapefruit, pomelo, sour orange, starfruit, pomegranate, or food/beverages prepared from these fruits within 7 days prior to screening;
- •Participants who used prescription drugs, over-the-counter drugs, herbal products, vitamins, or minerals within 2 weeks prior to screening, or failed to complete at least 5 half-lives of elimination for previously used drugs, whichever is longer;
- •Participants who used any psychotropic drugs or psychoactive substances within 1 year prior to screening (psychoactive substances include central nervous system depressants, stimulants, hallucinogens, opioids, volatile solvents, novel psychoactive substances, etc.);
- •Pregnant or lactating women, or female participants with a positive pregnancy test at screening;
- •Participants with a history of surgery that affects the in vivo disposition of drugs, or any surgery within 3 months prior to screening, or planned surgery during the study period;
- •Participants who have hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption (history of diarrhea after drinking milk);
- •Participants with any other condition deemed by the investigator as unsuitable for participation in this study, or withdrawal of consent for personal reasons.
研究组 & 干预措施
Sequence A of bioequivalence study.
In Period 1, subjects receive the new formulation; in Period 2, the Phase III formulation; in Period 3, the new formulation; and in Period 4, the Phase III formulation.
干预措施: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) (Drug)
Sequence A of bioequivalence study.
In Period 1, subjects receive the new formulation; in Period 2, the Phase III formulation; in Period 3, the new formulation; and in Period 4, the Phase III formulation.
干预措施: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation) (Drug)
Sequence B of bioequivalence study.
In Period 1, subjects receive the Phase III formulation; in Period 2, the new formulation; in Period 3, the Phase III formulation; and in Period 4, the new formulation
干预措施: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) (Drug)
Sequence B of bioequivalence study.
In Period 1, subjects receive the Phase III formulation; in Period 2, the new formulation; in Period 3, the Phase III formulation; and in Period 4, the new formulation
干预措施: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation) (Drug)
Sequence C of food effect study.
In Period 1, the new formulation is administered under fasting conditions; in Period 2, the new formulation is administered 1 hour after a high-fat meal.
干预措施: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) (Drug)
Sequence D of food effect study.
In Period 1, the new formulation is administered 1 hour after a high-fat meal; in Period 2, the new formulation is administered under fasting conditions.
干预措施: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) (Drug)
结局指标
主要结局
Plasma Maximum concentration (Cmax)
时间窗: Up to 60 hours
Area under the concentration-time curve (AUC)
时间窗: Up to 60 hours
次要结局
- Half-Life (t1/2)(Up to 60 hours)
- Absorption lag time(Tlag)(Up to 60 hours)
- Time to maximum plasma concentration(Tmax)(Up to 60 hours)
- Apparent volume of distribution during the terminal phase (Vz/F)(Up to 60 hours)
- Apparent total clearance (CL/F)(Up to 60 hours)
- The Incidenceof adverse events (AEs)(Up to 60 hours)