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

NCT00743912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-11-29

No results posted yet for this study

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.

Conditions

  • Pharmacokinetic

Interventions

DRUG

rifaximin

550 mg TID

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • William Lewis, MD · Covance CRU, Inc

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-10-31
Completion
2008-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00743912 on ClinicalTrials.gov