NCT01537250

Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

A Multi-center, Randomized, Double-blind, Double-dummy Parallel-controlled Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: TaiGen Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.

Detailed description

Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.

Conditions

• Community-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Levofloxacin 500 mg placebol	oral form,,once adily,7\~10 days
DRUG	Levofloxacin 500 mg placebol	oral form,,once adily,7\~10 days
DRUG	Nemonoxacin 3 tablets	oral form,once daily,7\~10 days

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2012-02-23
• Last updated: 2018-01-24

Locations

32 sites across 1 country: China