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

NCT02498418 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 739

Last updated 2019-12-05

Study results available
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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.

Conditions

Interventions

DRUG

Rifaximin

Tablets, generic formulation of the brand product.

DRUG

Xifaxan®

Tablets, brand product.

DRUG

Placebo Tablet

Placebo tablets in the same image of the generic rifaximin. Has no active ingredient.

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Actavis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-06
Primary Completion
2017-02-28
Completion
2017-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02498418 on ClinicalTrials.gov