NCT01395108

Clinical Study on Oral Nemonoxacin Malate Capsules

Phase I Clinical Study on Oral Nemonoxacin Malate Capsules

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (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 study: evaluate safety and tolerability of oral nemonoxacin 125 mg, 250mg, 500mg, 750mg, and 1000mg. Multiple dose study: evaluate PK profile of oral doses of 500mg or 750mg nemo after consecutive 10 days.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Nemonoxacin	oral once daily

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2011-07-15
• Last updated: 2011-07-15

Locations

1 site across 1 country: China