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| Name | Class |
|---|---|
| Zhuhai Essex Bio-Pharmaceutical Company Limited | UNKNOWN |
| Panacea Technologies | OTHER |
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To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the original azithromycin eye drops, and evaluate the release behavior of both in the eye.
There are 48 patients will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| azithromycin eye drops by essex | Experimental | In one cycle, give the azithromycin eye drops by essex,2.5ml/25mg,1 drop,once. In the second cycle(after 14 days elution),give the AzaSite eye drops,2.5ml/25mg,1 drop,once. |
|
| AzaSite | Active Comparator | In one cycle, give the AzaSite eye drops,2.5ml/25mg,1 drop,once. In the second cycle(after 14 days elution),give the azithromycin eye drops by essex,2.5ml/25mg,1 drop,once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azithromycin eye drops by essex | Drug | azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL), |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours,The AUC of the test drug and the control drug was calculated at the average concentration of each point | The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours,The Cmax of the test drug and the control drug was calculated at the average concentration of each point | The tear samples were taken at 8 time points after administration,10 minutes,half hour,2 hours,4 hours,8 hours,12 hours,24 hours,36 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuli Zhao, Doctor | Contact | +86-13911901818 | XL_Zhao_YLJD@163.com | |
| Siyang Ni, Doctor | Contact | +86-18911810275 | grandnsy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Zhao | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 25, 2022 | |
| Reset | Jun 30, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 25, 2022 | Jun 30, 2023 |
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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There are 8 subjects will be enrolled in pre-test, each subject was sampled in two eyes and each subject participated in two cycles of the trial. 8 subjects, 16 eyes participated in the study, 32 samples of tears total .
There are 48 subjects will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.
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| azithromycin eye drops | Drug | azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc |
|
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| AE | compared the laboratory test values before and after treatment,according to the study drug use, calculate the number of cases, the number of cases and the incidence of adverse reactions. | from the ICF signed to the end of the trial,through study completion, an average of 1 year |
| SAE | Any serious adverse events that occur during the clinical study, whether or not related to the drug should be collected. | from the ICF signed to the end of the trial,through study completion, an average of 1 year |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| Organic Chemicals |