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The goal of this clinical trial is:
1)To evaluate the pharmacokinetic profiles and safety of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects after multiple dosing; 2)To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% Timolol Maleate Gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects.
The main questions aim to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5%TM | Experimental | 18 subjects will receive one drop of 0.5% timolol maleate ophthalmic gel forming solution each in the left and right eyes once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% TM | Drug | From D1 to D10, each subject will receive one drop of 0.5% timolol maleate ophthalmic gel forming solution each in the left and right eyes once daily at the same time every day under fasted condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss | maximum plasma concentration at steady state | 24 hours after administration |
| AUC0-t,ss | area under the plasma concentration-time curve from the last dose to the collection time t of the last measurable concentration | 24 hours after administration |
| AUC0-24,ss | area under the plasma concentration-time curve over a 24-h dosing interval at steady state | 24 hours after administration |
| AUC0-∞,ss | area under the plasma concentration-time curve extrapolated from the last dose to infinity at steady state | 24 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huzhou Central Hospital | Huzhou | Zhejiang | 313000 | China |
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