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Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP

NCT01529476 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2013-06-18

No results posted yet for this study

Summary

1. This study will test the safety and efficacy of TG-873870 (Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP)
2. To investigate the population pharmacokinetics (PPK) of nemonoxacin in adult patients with CAP after continuous oral administration and determine the pharmacokinetic (PK)/pharmacodynamic (PD).

Conditions

Interventions

DRUG

Levofloxacin

levofloxacin 500 mg,QD,7\~10 days

DRUG

Nemonoxacin

Nemonoxacin 500mg,QD,7\~10 days

Sponsors & Collaborators

  • Qualitix Clinical Research Co., Ltd.

    collaborator INDUSTRY

  • Parexel

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • TaiGen Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-08-31
Completion
2012-12-31

Countries

  • China
  • Taiwan

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 NCT01529476 on ClinicalTrials.gov