An Open Label, Single And Repeat Dose Randomized Crossover Study To Estimate The Pharmacokinetics And Safety Of Eletriptan Hydrobromide Tablets In Healthy Korean Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC From Time Zero to Last Quantifiable Concentration (AUClast)
研究概览
简要总结
The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male subjects, 18-55 years old
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
- •provide informed consent
排除标准
- •blood pressure >140/90 mm Hg
- •any condition possibly affecting drug absorption
- •positive urine drug screen
研究组 & 干预措施
Treatment A
1 X 20 mg eletriptan
干预措施: Eletriptan commercial tablet (Drug)
Treatment B
1 X 40 mg eletriptan
干预措施: Eletriptan commercial tablet (Drug)
Treatment C
2 X 40 mg eletriptan
干预措施: Eletriptan commercial tablet (Drug)
Treatment D
1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose
干预措施: Eletriptan commercial tablet (Drug)
结局指标
主要结局
AUC From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
时间窗: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Maximum Observed Plasma Concentration (Cmax)
时间窗: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
次要结局
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D))
- Plasma Decay Half Life (t1/2)(Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D))