NCT03675841

Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media

A Phase I，Pazufloxacin Mesilate Ear Drops in Patients With Chronic Suppurative Otitis Media

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.

Detailed description

The test group was completed in sequence from low to high concentrations, and safety tolerance was assessed after administration in one concentration group to determine whether to conduct follow-up group studies and, if necessary, adjust sampling time points according to pre-experimental results.

Conditions

• Chronic Suppurative Otitis Media

Interventions

Type	Name	Description
DRUG	Pazufloxacin Mesilate ear drops	Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%

Timeline

• Start date: 2018-07-29
• Primary completion: 2019-01-30
• Completion: 2019-06-28
• First posted: 2018-09-18
• Last updated: 2018-09-26

Locations

1 site across 1 country: China