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| ID | Type | Description | Link |
|---|---|---|---|
| CRC-C1824 | Other Identifier | China Drug Trials |
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The goal of this clinical trial is to to evaluate the safety, tolerance, and pharmacokinetic profiles of Timolol Maleate Gel in healthy Chinese adult subjects. The main questions aim to answer are:
• The pharmacokinetic endpoints: Single dose:Tmax, Cmax, etc. Multiple doses:AUC0-t, AUC0-inf, λz, t1/2, etc.
• The safety and tolerance endpoints: Physical examination, vital signs, 12-lead ECG, laboratory tests (hematology, blood biochemistry and urinalysis), adverse events, local tolerance.
Researchers will compare TM gel to a placebo (a look-alike substance that contains no drug) to see if TM gel works to treat IH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2-0.5%TM | Experimental | Participants will be randomized to receive 0.5%TM or matching placebo 2 times a day. |
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| Group 3-0.5%TM | Experimental | Participants will be randomized to receive 0.5%TM or matching placebo 3 times a day. |
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| Group 1-0.5%TM | Experimental | Participants will be randomized to receive 0.5%TM or matching placebo 1 time a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol Maleate Gel | Drug | A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel one time a day during Day 3-Day 12. |
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| Measure | Description | Time Frame |
|---|---|---|
| Local tolerance | Local tolerance will be evaluated by an investigator or designated evaluator (e.g., dermatologist) using the blinding method.The intensity (e.g., No evidence of irritation;Minimal erythema that is barely perceptible;Definite erythema that is readily visible and minimal edema or minimal papular response;Erythema and papules, et al) of the skin response is assessed on a 8 point scale.Other response score is assessed from "A" to "H". | 13 Days |
| Adverse events | Frequency, severity and relatedness of adverse events | Throughout study completion, an average 13 days |
| Vital signs (blood pressure) | Number of participants with clinically significant changes in vital signs (blood pressure) | the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13. |
| Vital signs (temperature) | Number of participants with clinically significant changes in vital signs (temperature) | the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13. |
| Vital signs (pulse rate) | Number of participants with clinically significant changes in vital signs (pulse rate) | the screening phase, Day -1, Day 1, 3, 6, 9, 12, and Day 13. |
| Laboratory tests | Number of participants with clinical laboratory abnormalities (including hematology, blood biochemistry and urinalysis). | the screening phase, the baseline phase, and on Days 6 and 13. |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | The pharmacokinetics of single and multiple dose levels in participants will include peak time. | Day1 to Day13 |
| Cmax | The pharmacokinetics of single and multiple dose levels in participants will include peak concentration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| Placebo | Drug | A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo one time a day during Day 3-Day 12. |
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| Timolol Maleate Gel | Drug | A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel 2 times a day during Day 3-Day 12. |
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| Placebo | Drug | A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo 2 times a day during Day 3-Day 12. |
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| Timolol Maleate Gel | Drug | A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel 3 times a day during Day 3-Day 12. |
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| Placebo | Drug | A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo 3 times a day during Day 3-Day 12. |
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| Physical examinations |
Number of participants with clinically significant changes in physical examinations. |
| the screening phase, baseline phase and on Day 13 |
| 12-lead ECG | Number of participants with clinically significant changes in 12-lead ECG. | the screening phase, baseline phase, Day 1, 3, 6, 9, 12, and Day 13. |
| Day1 to Day13 |
| AUC0-t | The pharmacokinetics of single and multiple dose levels in participants will include area under drug concentration-time curve. | Day1 to Day13 |
| AUC0-inf | area under drug concentration-time curve (AUC0-t) from 0 to t for the last accurately measurable concentration, area under drug concentration-time curve from 0 to infinity | Day1 to Day13 |
| λz | The pharmacokinetics of single and multiple dose levels in participants will include elimination rate constant. | Day1 to Day13 |
| t1/2 | The pharmacokinetics of single and multiple dose levels in participants will include elimination half-life. | Day1 to Day13 |
| %AUCex | The pharmacokinetics of single and multiple dose levels in participants will include AUC extrapolation percentage. | Day1 to Day13 |