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This is to characterize STN1013800 active ingredient bioavailability following multiple-dose ocular administration of STN1013800 to both eyes in healthy adults.
It is a PK study with screening period of up to 28 days + dosing period of 7 days + Follow-up period of 2 days.
At present, there are no medicines for the treatment of acquired blepharoptosis in China.
Therefore, efficacy and safety phase III study is also currently being conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STN1013800 ophthalmic solution | Experimental | 0.1% STN1013800 ophthalmic solution administered once daily (QD) for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STN1013800 ophthalmic solution | Drug | Investigational Product: 0.1% STN1013800 ophthalmic solution once daily (QD) (9AM ± 60 min), one drop for each eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK (Pharmacokinetic) parameter to measure: Cmax | Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Cmax - Peak concentration | Day 1, 5, 6, and 7 |
| PK parameter to measure: Cmin | Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Cmin - Minimum concentration | Day 1, 5, 6, and 7 |
| PK parameter to measure: Tmax | Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Tmax - Peak time | Day 1, 5, 6, and 7 |
| PK parameter to measure: AUC0-24h | Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUC0-24h - The area under the drug-time curve for the quantifiable time period from 0 to 24 hours after drug administration. | Day 1, 5, 6, and 7 |
| PK parameter to measure: AUC0-36h | Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUC0-36h - The area under the drug-time curve from 0 to 36 hours after drug administration | Day 1, 5, 6, and 7 |
| PK parameter to measure: AUCinf | Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUCinf - The area under the drug-time curve from 0 to infinity after drug administration | Day 1, 5, 6, and 7 |
| PK parameter to measure: kel | Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. kel - Elimination rate constant. The negative of the slope value obtained by taking the logarithm of the plasma concentration in the vanishing phase of the time curve and performing linear regression on time obtained. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| Day 1, 5, 6, and 7 |
| PK parameter to measure: t½ | Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. t½ - Elimination half-life | Day 1, 5, 6, and 7 |