A Phase 1, Randomized, Partially-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of Entecavir Extended Release (XR) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses in healthy subjects.
研究概览
简要总结
This is a phase 1, randomized, parallel-group, single-center study in healthy adult subjects. The study will be conducted in two parts sequentially:
Part 1 is an open-label, two-arm, active-controlled design to evaluate the PK and safety of single oral dose of ETV XR tablet (1.5 mg) in healthy subjects. Part 1 will consist of 16 healthy subjects.
Part 2 is a double-blind, three-arm, placebo-controlled design to evaluate the PK and safety of higher oral doses of ETV XR tablet (3 mg and 6 mg) in healthy subjects. Part 2 will consist of 24 healthy 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
- Double (Participant, Care Provider)
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
1.5 mg ETV XR tablet
干预措施: Entecavir (Drug)
3 mg ETV XR tablet
干预措施: Entecavir (Drug)
6 mg ETV XR tablet
干预措施: Entecavir (Drug)
Placebo-to-match 1.5 mg ETV XR tablet
干预措施: Entecavir (Drug)
0.5 mg ETV IR tablet
干预措施: Entecavir (Drug)
结局指标
主要结局
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses in healthy subjects.
时间窗: 22 days
Peak Plasma Concentration(Cmax)
To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses
时间窗: 22 days
half life (t1/2)
次要结局
- To assess ETV XR tablet in healthy subjects.(22 days)
- To evaluate the dose linearity of ETV XR tablet(60 days)