A Single Center, Open-label, Randomized, 3-arm, 3-way, Crossover Trial to Investigate the Bioequivalence of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets in Healthy Adult Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Brexpiprazole
研究概览
简要总结
To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese males
- •BMI ［body weight in kg /(height in m)2］ of at least 18.5 kg/m2 and less than 25.0 kg/m2 (as a result of at the screening examination)
- •Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial
排除标准
- •Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator, subinvestigator, or sponsor may place the subject at risk or interfere with outcome variables such as drug absorption, distribution, metabolism, and excretion
- •History of serious mental disorder
- •History of drug or alcohol abuse within 2 years prior to screening
- •History of any significant drug allergy
- •Use of another investigational drug within 120 days prior to the first administration of IMP
- •Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, Star fruit, or Star fruit products within 72 hours prior to the first administration of IMP or consumption of alcohol within 72 hours prior to administration of IMP
- •Use of prescription, over-the-counter (OTC), or herbal medication, or vitamin supplements, or consumption of food or beverages containing St. John's Wort within 14 days prior to the first administration of IMP, or use of antibiotics within 30 days prior to the first administration of IMP
- •History of major surgery of the digestive tract (excluding appendectomy)
- •Any subject who, in the judgement of the investigator or subinvestigator, should not participate in the trial
研究组 & 干预措施
Brexpiprazole ODT 2mg with water
Brexpiprazole ODT 2mg is administered with water.
干预措施: Brexpiprazole ODT 2mg with water (Drug)
Brexpiprazole ODT 2mg without water
Brexpiprazole ODT 2mg is administered without water.
干预措施: Brexpiprazole ODT 2mg without water (Drug)
Brexpiprazole conventional tablet 2mg
Brexpiprazole conventional tablet 2mg is administered with water.
干预措施: Brexpiprazole conventional tablet 2mg (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Brexpiprazole
时间窗: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose
Maximum (Peak) Plasma Concentration (Cmax) of Brexpiprazole
时间窗: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours postdose
次要结局
未报告次要终点