Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

A Single Dose Phase I Clinical Study of Pazufloxacin Mesilate Ear Drops for the Patients With Otitis Media

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02592096

Enrollment

Registered

2015-10-30

Start date

2015-07-31

Completion date

2016-02-29

Last updated

2015-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media

Keywords

safety and bioavailability

Brief summary

To investigate the safety, tolerance, dynamic percolation model of single dose usage pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic suppurative otitis media

Interventions

DRUG0.1% Pazufloxacin Mesilate Ear Drops

DRUG0.3% Pazufloxacin Mesilate Ear Drops

DRUG0.5% Pazufloxacin Mesilate Ear Drops

DRUGPazufloxacin mesilate injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Aged 18-65 years old, both gender; 2. Patients with acute or chronic suppurative otitis media, need to be treated partially by antimicrobial agents; 3. Written informed consent form.

Exclusion criteria

1. Allergic to quinolones antibiotics or severe allergic constitution; 2. Not able to collect otorrhea during the trial; 3. High severity with the need of combined antibiotics treatment; 4. Induced by pathogens, e.g.: fungus, virus (myringitis bullosa); 5. Combined otitis externa (e.g.: ear cellulitis, mumps), intracranial or extracranial complication (meningitis, cerebral abscess, thrombophlebitis of sigmoid sinus, Bezold's abscess, ear subperiosteal abscess); 6. Severe disease of cerebral, cardiopulmonary, renal hepatic, circulatory system; 7. Life-threatening disease, e.g.: malignant tumor or AIDS. 8. Renal hepatic dysfunction (ALT, AST ≥ 1.5 times of normal maximum level, Cr \> normal maximum level); 9. Confirmed or suspected of alcohol/drug abuse record; 10. Neurological or psychiatric disease leading to inability of cooperation or not willing to follow the protocol or instruction; 11. Feminine patients who are in gestational, lactation period or having a birth plan in short-term; 12. Enrolled into other clinical trial in the past 3 months; 13. Not suitable for this trial according to investigator's judgment;

Design outcomes

Primary

Measure	Time frame	Description
safety and tolerance of pazufloxacin mesilate ear drops	24 hours	Any changes in vital signs; AE/SAE number

Secondary

Measure	Time frame	Description
PK of pazufloxacin mesilate ear drops	24 hours	blood samples will be collected at 0, 0.5, and one of the followed time points 2, 4, 6, 8 hours. AUC will be calculated based on the pazufloxacin mesilate concentration at above timepoints in blood.

Countries

China

Contacts

Primary ContactWeiguo Xue, MD

+86-532-82789159

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026