Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea

Status Completed

Clinical Trial Summary

The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day (TID) for 3 days in participants with travelers' diarrhea.

Clinical Trial Description

This is a randomized, placebo-controlled bioequivalent study with a clinical endpoint in the treatment of travelers' diarrhea. After 3 unformed stools are recorded within the 24 hours immediately preceding randomization, participants are to be randomized to receive the generic rifaximin 200 mg oral tablet, Xifaxan (the reference listed drug)200 mg oral tablet, or placebo 3 times daily for 3 days (that is; on Days 1, 2, and 3). ;

Study Design

Related Conditions & MeSH terms

Diarrhea

Clinical Trial Details

NCT number	NCT02498418
Study type	Interventional
Source	Actavis Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	January 6, 2016
Completion date	February 28, 2017

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