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A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers

NCT06462326 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-11-01

No results posted yet for this study

Summary

This is a randomized (1:1), double-blind, double-dummy, phase I study to compare the effects of Omadacycline versus Moxifloxacin on gut microbiota and the resistomes in healthy adult volunteers.The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Moxifloxacin Oral Tablet

400mg per tablet

DRUG

Omadacycline Oral Tablet

150 mg per tablet

Sponsors & Collaborators

  • Zai Lab (Hong Kong), Ltd.

    lead INDUSTRY

Principal Investigators

  • Jian Liu · Zhejiang University

  • Yonghong Xiao · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2024-09-29
Completion
2024-09-29
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT06462326 on ClinicalTrials.gov