A Single-center, Open-label, Randomized, Three-way, Crossover Trial to Evaluate the Bioavailability of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets Relative to Brexpiprazole (OPC-34712) Conventional Tablets in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Maximum Plasma Concentration (Cmax) of OPC-34712
研究概览
简要总结
The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 交叉
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 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 or sponsor may place the subject at risk or interfere with outcome variables, including 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 an investigational drug within 120 days prior to the first dosing of trial drug
- Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to screening
- Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, starfruit, or starfruit products within 72 hours prior to dosing
- Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or St. John's Wort within 14 days prior to the first dosing of trial drug, or of antibiotics within 30 days prior to the first dosing of trial drug
- History of major surgery of the digestive tract (excluding appendectomy)
- Any subject who, in the opinion of the investigator, should not participate in the trial
研究组 & 干预措施
OPC-34712 disintegrating tablet with water
OPC-34712 (4 mg) orally disintegrating tablet is administered with water.
干预措施: OPC-34712 (Drug)
OPC-34712 disintegrating tablet without water
OPC-34712 (4 mg) orally disintegrating tablet is administered without water.
干预措施: OPC-34712 (Drug)
OPC-34712 conventional tablet with water
OPC-34712 (4 mg) conventional tablet is administered with water.
干预措施: OPC-34712 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of OPC-34712
时间窗: Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120，144, 168, 216, 264, and 312 hours postdose
To evaluate Cmax of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) of OPC-34712
时间窗: Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120，144, 168, 216, 264, and 312 hours postdose
To evaluate AUC∞ of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation
次要结局
未报告次要终点
研究者
标识符
- NCT 编号
- NCT02875080
- 其他研究编号
- 331-102-00019, JapicCTI-163351
日期
- 首次提交
- (10年前)
- 首次发布
- (10年前)
- 主要完成日期
- (9年前)
- 研究完成日期
- (9年前)
- 最近核实
- 最近更新
- (5年前)
监管与共享
- FDA 监管药物
- 否
- 是否有结果
- 是