A Multiple-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses 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 dry syrup after multiple oral doses in healthy male Japanese 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
- •Participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (ICF)
- •Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (ie, participant has all 4 Japanese grandparents born in Japan)
- •Participant is male
排除标准
- •Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) formulations
- •Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days or within 5 times the half-life (whichever is longer) of the first dose of BRV in this study or is currently participating in another study of an IMP (and/or an investigational device)
- •Participant tests positive for alcohol and/or prohibited concomitant drugs (including cotinine) at the Screening Visit or on Day-1
- •Participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP
- •Participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP
研究组 & 干预措施
Treatment A-B
Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.
干预措施: brivaracetam (BRV) tablet (Drug)
Treatment A-B
Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.
干预措施: brivaracetam (BRV) dry syrup (Drug)
Treatment B-A
Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.
干预措施: brivaracetam (BRV) tablet (Drug)
Treatment B-A
Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.
干预措施: brivaracetam (BRV) dry syrup (Drug)
结局指标
主要结局
Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam
时间窗: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose
Cmax,ss is the maximum plasma concentration of brivaracetam at steady state.
Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam
时间窗: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose
AUCtau was area under the curve during a dosing interval at steady state of brivaracetam.
次要结局
- Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs)(From Baseline to end of Safety Follow-up (up to 25 days))
- Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs)(From Baseline to end of Safety Follow-up (up to 25 days))
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation(From Baseline to end of Safety Follow-up (up to 25 days))