Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered Silymarin (Legalon) in Non-Cirrhotic Subjects With Chronic Hepatitis C or Non-Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 5
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of different dosages of silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Placebo and 140 mg single dose + every 8 hours
干预措施: Placebo (Drug)
Group 2
Placebo and 280 mg single dose
干预措施: Placebo (Drug)
Group 3
Placebo and 280mg every 8 hours
干预措施: Placebo (Drug)
Group 4
Placebo and 280 single dose + every 8 hours
干预措施: Placebo (Drug)
Group 5
Placebo and 560 mg single dose + every 8 hours
干预措施: Placebo (Drug)
Group 6
Placebo and 560 mg single dose + every 8 hours
干预措施: Placebo (Drug)
Group 7
Placebo and 700 mg single dose + every 8 hours
干预措施: Placebo (Drug)
Group 2
Placebo and 280 mg single dose
干预措施: Silymarin (Drug)
Group 7
Placebo and 700 mg single dose + every 8 hours
干预措施: Silymarin (Drug)
Group 3
Placebo and 280mg every 8 hours
干预措施: Silymarin (Drug)
Group 4
Placebo and 280 single dose + every 8 hours
干预措施: Silymarin (Drug)
Group 5
Placebo and 560 mg single dose + every 8 hours
干预措施: Silymarin (Drug)
Group 6
Placebo and 560 mg single dose + every 8 hours
干预措施: Silymarin (Drug)
Group 1
Placebo and 140 mg single dose + every 8 hours
干预措施: Silymarin (Drug)
结局指标
主要结局
Adverse events
时间窗: 10 days
次要结局
未报告次要终点