Status:
COMPLETED
Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Pharmacokinetic
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 midaz...
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) ...
Eligibility Criteria
Inclusion
- Patient is medically normal
- Patient has normal laboratory values
- Patient has the ability to understand the requirements of the study
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00743912
Start Date
September 1 2008
End Date
November 1 2008
Last Update
November 29 2019
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