Open Label Study to Evaluate the Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy Subjects and Subjects With Severe Hepatic Impairment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration Versus Time Curve (AUC) During the 12-hour Dose Interval
研究概览
简要总结
The primary objective of this study is to characterize the steady state plasma
详细描述
The primary objective of this study is to characterize the steady state plasma PK of rifaximin (550 mg BID) in subjects with severe hepatic impairment (MELD 19 to 25 and MELD >25), as well as healthy subjects with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically impaired subjects will have a MELD score of >25.
排除标准
- •Subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients and/or vehicles used in the formulation, or any other clinically significant allergies.
- •Subject has participated in an investigational drug or device study within 30 days prior to Day 1 (Baseline).
- •Subject has any concurrent illness (other than liver cirrhosis), disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the investigator.
研究组 & 干预措施
Rifaximin
Rifaximin 550 mg BID
干预措施: Rifaximin (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Versus Time Curve (AUC) During the 12-hour Dose Interval
时间窗: 7 days
Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable
Time of the Maximum Concentration (Tmax)
时间窗: 7 days
Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable
Maximum Observed Plasma Concentration (Cmax)
时间窗: 7 days
Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable
次要结局
未报告次要终点