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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pharmacokinetic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

open-label rifaximin 550 mg TID

Group Type EXPERIMENTAL

rifaximin

Intervention Type DRUG

550 mg TID

Interventions

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rifaximin

550 mg TID

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes