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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1% Pazufloxacin Mesilate Ear Drops | Experimental | 10 drips for ear dropping, 10 minutes for ear bath |
|
| 0.3% Pazufloxacin Mesilate Ear Drops | Experimental | 10 drips for ear dropping, 10 minutes for ear bath |
|
| 0.5% Pazufloxacin Mesilate Ear Drops | Experimental | 10 drips for ear dropping, 10 minutes for ear bath |
|
| Pazufloxacin mesilate injection | Active Comparator | 0.3g, 30 minutes for ventricular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1% Pazufloxacin Mesilate Ear Drops | Drug |
| ||
| 0.3% Pazufloxacin Mesilate Ear Drops |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerance of pazufloxacin mesilate ear drops | Any changes in vital signs; AE/SAE number | 24 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiguo Xue, MD | Contact | +86-532-82789159 |
| Name | Affiliation | Role |
|---|---|---|
| Weiguo Cue, MD | Qingdao Municipal Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingdao Municipal Hospital | Recruiting | Qingdao | 266011 | China |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Drug |
|
| 0.5% Pazufloxacin Mesilate Ear Drops | Drug |
|
| Pazufloxacin mesilate injection | Drug |
|
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 |