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Randomised, Placebo-controlled Safety and Pharmacokinetics Study of Novel Rifaximin Formulations in Healthy Volunteers

NCT04529811 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2021-06-18

No results posted yet for this study

Summary

Phase 1, Randomised, Placebo-Controlled, Single-Ascending Dose and Multiple-Dose with 3 novel RIFAXIMIN Formulations.

2 phases: Single-Ascending Dose (SAD) Phase and a Multiple-Dose (MD) Phase, Plus optional open-label, crossover Food Effect (FE) Evaluation

Primary objective: evaluate the safety and tolerability of three novel formulations of rifaximin in healthy volunteers.

Secondary objective: evaluate the pharmacokinetics (PK) of the novel formulations and to assess for the presence of exploratory biomarkers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Rifaximin Novel Formulation

Rifaximin Novel Formulation

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Christian Schwabe, MD · Auckland Clinical Studies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2021-05-09
Completion
2021-05-09

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

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 NCT04529811 on ClinicalTrials.gov