Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol

Study Overview
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Brief Summary
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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

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

Conditions
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Otitis Media

Intervention / Treatment
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* Drug: 0.1% Pazufloxacin Mesilate Ear Drops
* Drug: 0.3% Pazufloxacin Mesilate Ear Drops
* Drug: 0.5% Pazufloxacin Mesilate Ear Drops
* Drug: Pazufloxacin mesilate injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-65 years old, both gender; Patients with acute or chronic suppurative otitis media, need to be treated partially by antimicrobial agents; Written informed consent form. Exclusion Criteria: Allergic to quinolones antibiotics or severe allergic constitution; Not able to collect otorrhea during the trial; High severity with the need of combined antibiotics treatment; Induced by pathogens, e.g.: fungus, virus (myringitis bullosa); 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); Severe disease of cerebral, cardiopulmonary, renal hepatic, circulatory system; Life-threatening disease, e.g.: malignant tumor or AIDS. Renal hepatic dysfunction (ALT, AST ≥ 1.5 times of normal maximum level, Cr > normal maximum level); Confirmed or suspected of alcohol/drug abuse record; Neurological or psychiatric disease leading to inability of cooperation or not willing to follow the protocol or instruction; Feminine patients who are in gestational, lactation period or having a birth plan in short-term; Enrolled into other clinical trial in the past 3 months; Not suitable for this trial according to investigator's judgment;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.1% Pazufloxacin Mesilate Ear Drops<br>10 drips for ear dropping, 10 minutes for ear bath | Drug: 0.1% Pazufloxacin Mesilate Ear Drops<br> <br> |
| Experimental: 0.3% Pazufloxacin Mesilate Ear Drops<br>10 drips for ear dropping, 10 minutes for ear bath | Drug: 0.3% Pazufloxacin Mesilate Ear Drops<br> <br> |
| Experimental: 0.5% Pazufloxacin Mesilate Ear Drops<br>10 drips for ear dropping, 10 minutes for ear bath | Drug: 0.5% Pazufloxacin Mesilate Ear Drops<br> <br> |
| Active Comparator: Pazufloxacin mesilate injection<br>0.3g, 30 minutes for ventricular injection | Drug: Pazufloxacin mesilate injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety and bioavailability