Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Midazolam; Rifamycins; Rifaximin

Criteria

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.