NCT02212795

Evaluation of Pharmacokinetics Profiles and Bactericidal Activity of Zabofloxacin

Phase I Study of Pharmacokinetics and Bacteriocidal Activity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Dong Wha Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer

Detailed description

A Randomized, open label, single dose, crossover phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zabofloxacin 183mg	Zabofloxacin 183mg single dose
DRUG	Levofloxacin 250mg	Levofloxacin 250mg single dose
DRUG	Zabofloxacin 367mg	Zabofloxacin 367mg single dose

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2014-08-08
• Last updated: 2015-06-29

Locations

1 site across 1 country: South Korea