Pharmacokinetics of Single and Multiple Oral Doses of 120 mg and 240 mg BI 201335 in Healthy Chinese Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Cmax,ss (After Multiple Dosing)
研究概览
简要总结
The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single oral dose and multiple oral doses in Chinese subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
faldaprevir(high dose)
10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.
干预措施: faldaprevir(high dose) (Drug)
Faldaprevir(low dose)
10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.
干预措施: Faldaprevir(low dose) (Drug)
结局指标
主要结局
Cmax,ss (After Multiple Dosing)
时间窗: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir
C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.
AUC(Tau,ss) (After Multiple Dosing)
时间窗: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir
AUC(tau,ss) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau.
次要结局
- Cmax (After Single Dosing)(Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir)
- AUC(0-tz) (After Single Dosing)(Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir)
- t(1/2,ss) (After Multiple Dosing)(Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir)
- Tmax,ss (After Multiple Dosing)(Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir)