A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam
研究概览
简要总结
The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV as dry syrup after a single oral dose in healthy Japanese male study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment A-B
Study participants randomized to this arm will receive a single dose of brivaracetam tablet (Treatment A) as reference and single dose of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.
干预措施: brivaracetam (Drug)
Treatment B-A
Study participants randomized to this arm will receive a single dose of brivaracetam tablet (Treatment A) as reference and single dose of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.
干预措施: brivaracetam (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam
时间窗: Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Cmax is the maximum plasma concentration of brivaracetam.
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam
时间窗: Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
AUC(0-t) is the area under the curve from time 0 to the time of the last quantifiable concentration.
次要结局
- Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)(From Baseline to end of Safety Follow-Up, up to 20 days)
- Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE)(From Baseline to end of Safety Follow-Up, up to 20 days)