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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00743912
Other study ID # RFDI1008
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2008
Est. completion date November 2008

Study information

Verified date November 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 24
Est. completion date November 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
rifaximin
550 mg TID

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized. 21 to 38 days (including a 21 day screening period)
Secondary 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
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