A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 100
- 主要终点
- Pharmacokinetics of Perampanel: AUC(0-t)
研究概览
简要总结
This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence between the oral suspension and tablet formulations of perampanel will be evaluated under fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet formulations will be evaluated under fed conditions. In both study arms, subjects will be randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for perampanel as either oral suspension or a tablet, and will then receive the alternative treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a washout of at least 6 weeks between the two treatment periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Perampanel - Group 1
Treatment A: Single oral dose of a 12-mg perampanel tablet under fasted condition.
Treatment B: Single 12 mg dose of perampanel oral suspension under fasted condition.
Subjects will be randomized on Study Day 1 for Treatment Period 1 to Treatment A or Treatment B. On Study Day 43 the subject will then receive the alternate Treatment for Treatment Period 2.
干预措施: Perampanel (Drug)
Perampanel - Group 2
Treatment C: Single oral dose of a 12-mg perampanel tablet co-administered with high fat meal.
Treatment D: Single 12 mg dose of perampanel oral suspension co-administered with high fat meal.
Subjects will be randomized on Study Day 1 for Treatment Period 1 to Treatment C or Treatment D. On Study Day 43 the subject will then receive the alternate Treatment for Treatment Period 2.
干预措施: Perampanel (Drug)
结局指标
主要结局
Pharmacokinetics of Perampanel: AUC(0-t)
时间窗: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: AUC(0-inf)
时间窗: Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: Cmax
时间窗: Up to 504 hours postdose in each treatment period
次要结局
- Pharmacokinetics of Perampanel: AUC(0-72h)(Up to 504 hours postdose in each treatment period)
- Pharmacokinetics of Perampanel: tmax(Up to 504 hours postdose in each treatment period)
- Pharmacokinetics of Perampanel: tlag(Up to 504 hours postdose in each treatment period)
- Pharmacokinetics of Perampanel: Lambda-z(Up to 504 hours postdose in each treatment period)
- Pharmacokinetics of Perampanel: t1/2(Up to 504 hours postdose in each treatment period)