NCT01529957

A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion

A Phase I Clinical Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: TaiGen Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.

Detailed description

Single dose safety and tolerability study: evaluate safety and tolerability of intravenous infusion nemonoxacin 25mg, 50mg, 125mg, 250mg, 500mg, 750mg, 1000mg and 1250mg. Single dose pharmacokinetic (PK) study:evaluate PK profile of doses of 250mg, 500mg or 750mg intravenous infusion nemonoxacin . Multiple dose study: evaluate PK profile of doses of 500mg, 650mg or 750mg intravenous infusion nemonoxacin after consecutive 10 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nemonoxacin Malate Sodium Chloride	Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2012-02-09
• Last updated: 2012-02-20

Locations

26 sites across 1 country: China