Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase 1, Single Arm, Open-Label Study to Evaluate the Effect of Rifaximin 550 MG Tablets TID on the Pharmacokinetics of Orally Administered Midazolam in Healthy Male and Female Volunteers|
- Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized. [ Time Frame: 21 to 38 days (including a 21 day screening period) ] [ Designated as safety issue: Yes ]
- 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. [ Time Frame: 21 tyo 38 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
open-label rifaximin 550 mg TID
550 mg TID
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743912
|Principal Investigator:||William Lewis, MD||Covance CRU, Inc|