A Phase 1, Single Arm, Open-Label Study to Evaluate the Effect of Rifaximin 550 MG Tablets TID on the Pharmacokinetics of Orally Administered Midazolam in Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized.
研究概览
简要总结
The primary objective of this study is to determine if rifaximin, administered daily has an effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.
详细描述
This is a single-site, single-arm, open-label, drug-interaction study that examines the effect of rifaximin (RFX), 550 mg 3 times daily (TID; 1650 mg/day), on orally administered (PO) midazolam (MDZ) 2 mg (administered as a 2 mg dose in 1 mL of midazolam HCL Syrup; 2 mg/mL) when dosed for 7 and 14 consecutive days, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient is medically normal
- •Patient has normal laboratory values
- •Patient has the ability to understand the requirements of the study
排除标准
- •Hepatitis B
- •Hepatitis C
- •History of renal, hepatic, endocrine, oncological, gastrointestinal or cardiovascular disease.
- •History of epilepsy, asthma, diabetes, psychosis, glaucoma or severe head injury.
研究组 & 干预措施
1
open-label rifaximin 550 mg TID
干预措施: rifaximin (Drug)
结局指标
主要结局
Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized.
时间窗: 21 to 38 days (including a 21 day screening period)
次要结局
- Overall safety assessments will include the incidence, intensity, and type of adverse events, and clinically significant changes in the patient's physical examination, vital signs and laboratory results.(21 tyo 38 days)