Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers
- Registration Number
- NCT00743912
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Patient is medically normal
- Patient has normal laboratory values
- Patient has the ability to understand the requirements of the study
Exclusion Criteria
- HIV
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 rifaximin open-label rifaximin 550 mg TID
- Primary Outcome Measures
Name Time Method Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized. 21 to 38 days (including a 21 day screening period)
- Secondary Outcome Measures
Name Time Method 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