NCT01240187已完成1 期
A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 6 x2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.
研究概览
简要总结
The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.
详细描述
A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.
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
- 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
- •Healthy male or female subjects aged between 18-55 years.
- •BMI of 18-32 kg/m ^
- •Willing and able to provide written informed consent.
- •Exclusion criteria:
- •Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
- •Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
- •Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
- •Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
- •Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
- •Subjects who consume more than five caffeinated beverages per day.
- •Subjects who smoke more than 5 cigarettes per day.
- •Subjects with a history of drug abuse or who have a positive urine drug screening test.
- •Women who do not agree to use two methods of contraception.
排除标准
- 未提供
研究组 & 干预措施
Experimental 1
Experimental
干预措施: perampanel (Drug)
Experimental 2
Experimental
干预措施: perampanel (Drug)
结局指标
主要结局
To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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