A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg

Summary

The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

DRUG

Zabofloxacin

Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days

DRUG

Moxifloxacin

Moxifloxacin 400mg tablet P.O. once daily for 7days

Sponsors & Collaborators

• Chonbuk National University Hospital

  collaborator OTHER

• Chosun University Hospital

  collaborator OTHER

• Bundang CHA Hospital

  collaborator OTHER

• Chungbuk National University

  collaborator OTHER

• Kangdong Sacred Heart Hospital

  collaborator OTHER

• Hanyang University

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Gachon University Gil Medical Center

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Konyang University Hospital

  collaborator OTHER

• KangWon National University Hospital

  collaborator OTHER

• Gyeongsang National University Hospital

  collaborator OTHER

• Kyunghee University Medical Center

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• DongGuk University

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Yeungnam University Hospital

  collaborator OTHER

• Ulsan University Hospital

  collaborator OTHER

• Ewha Womans University Mokdong Hospital

  collaborator OTHER

• Inje University

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Catholic University of Korea Saint Paul's Hospital

  collaborator OTHER

• Incheon St.Mary's Hospital

  collaborator OTHER

• Masan Samsung Hospital, South Korea

  collaborator OTHER

• Konkuk University Medical Center

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Wonju Severance Christian Hospital

  collaborator OTHER

• Hallym University Medical Center

  collaborator OTHER

• Ajou University

  collaborator OTHER

• Chungnam National University Hospital

  collaborator OTHER

• Dong Wha Pharmaceutical Co. Ltd.

  lead INDUSTRY

Principal Investigators

• Yeon-Mok Oh, M.D. · Asan Medical Center

• Sang-Do Lee, M.D. · Asan Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2014-01-31

Completion

2014-08-31

Countries

• South Korea

Study Locations