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Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1% single-dose pre | Experimental | Three subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose |
|
| 0.1% single-dose | Experimental | Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.1% single dose |
|
| 0.3% single-dose | Experimental | Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.3% single dose |
|
| 0.5% single-dose | Experimental | Ten subjects will be treated with Pazufloxacin Mesilate ear drops 0.5% single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pazufloxacin Mesilate ear drops | Drug | Pazufloxacin Mesilate ear drops of 0.1%,0.3%,0.5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Objective To observe the safety and tolerability of Pazufloxacin Mesylate Ear Drops of different concentrations in patients with simple chronic suppurative otitis media. | Within two days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetics | Within two days after administration |
| Tmax | Pharmacokinetics | Within two days after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lei chen, PHD | Contact | 13776620807 | jspent@126.com | |
| fen shao, PHD | Contact | 13851691161 | shaofengnj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| lei chen, PHD | Jiangsu Province People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province People's Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D014508 | Urea |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Area under concentration time curve | Pharmacokinetics | Within two days after administration |