A Randomized, Single-center, Open-label, 5-way Crossover, Single-dose Bioavailability/Bioequivalence Comparison of Brivaracetam Oral Tablets (10 mg, 50 mg,75 mg, and 100 mg) and Brivaracetam Intravenous Bolus Injection (100 mg) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration of Brivaracetam dose-normalized to the 50 mg reference treatment (Cmax)
研究概览
简要总结
To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a healthy male or female volunteer aged 18-55 years inclusive
- •Subject has a Body Mass Index (BMI) of 18.0 - 30.0 kg/m^2 and a weight of at least 50 kg (males) or 45 kg (females)
- •Subject has normal vital signs values, Electrocardiograms (ECGs) and clinical laboratory values
- •Female subjects should have a negative pregnancy test or be of non-childbearing potential
排除标准
- •Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
- •Volunteer is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
- •Subject has an intolerance or allergy against the compound or related drugs
结局指标
主要结局
Maximum plasma concentration of Brivaracetam dose-normalized to the 50 mg reference treatment (Cmax)
时间窗: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification dose-normalized to the 50 mg reference treatment (AUC[0-t])
时间窗: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Area under the plasma concentration-time curve from zero to infinity dose-normalized to the 50 mg reference treatment (AUC)
时间窗: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
次要结局
- Plasma half-life of Brivaracetam(Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose)
- Time to reach the maximum plasma concentration of Brivaracetam (tmax)(Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose)
- Apparent oral clearance of Brivaracetam (CL/F)(Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose)
- Apparent volume of Brivaracetam distribution at the terminal elimination phase(Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose)