NCT01260155已完成1 期
A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To determine the bioavailability (BA) of E5501 in one 40 mg new tablet formulation relative to two 20 mg old tablet formulation.
研究概览
简要总结
This study will be a single-center, open-label, randomized, 3-treatment crossover bioavailability study of single oral doses of E5501 old tablet formulation under fasted conditions and a new tablet formulation administered under fed and fasted conditions in healthy 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy adult males and females (age 18-45 years)
- •Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 32 at the time of Screening
- •All females must have a negative serum human beta-chorionic gonadotropin test result or negative urine pregnancy test result at Screening and Baseline. Females of child-bearing potential must use a medically acceptable method of contraception throughout the entire study period and for 30 days after study drug discontinuation. Postmenopausal women and women who have been surgically sterilized or are proven sterile are exempt from this requirement. All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
- •Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of child-bearing potential must use, or their partners must use, a highly effective,method of contraception starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days after the last dose of study drug.
- •Willing and able to comply with all aspects of the protocol
- •Provide written informed consent
排除标准
- •Standard selection criteria typically used in all protocols
- •Clinically significant abnormal laboratory test results, including platelet count and electrolyte abnormalities at Screening and at each Baseline
研究组 & 干预措施
Treatment A Fasted
Experimental
干预措施: E5501 (Drug)
Treatment B Fasted
Experimental
干预措施: E5501 (Drug)
Treatment C Food Effect
Experimental
干预措施: E5501 (Drug)
结局指标
主要结局
To determine the bioavailability (BA) of E5501 in one 40 mg new tablet formulation relative to two 20 mg old tablet formulation.
时间窗: 2 months
次要结局
- To evaluate the safety of E5501 in healthy subjects.(2 months)
- To determine the effect of a high fat meal on the BA of E5501 in one 40 mg new tablet formulation(2 months)
研究者
研究点 (1)
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