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The subjects of this study were healthy subjects, who were given medicine in a single dose group: 0.004%.
Tear collection was conducted on the single dose D1 (that is, the day of administration). Collection points: 10 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, and 12 h after administration.Each time 5-50 mg (generally 20 mg), a total of 160-1600 mg of tears will be collected (during the screening period, all subjects will retain the tear samples collected by the Schirmer filter paper, among which, qualified tear samples will be used for blank samples or methodological investigation.After administration, only 1 tear collection site will be collected for each subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.004% single-dose | Experimental | 96 subjects will be treated with Germinal peptide eye drops 0.004% single dose (16 were pre-tested and 64 were formally tested). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Germinal peptide eye drops | Drug | Germinal peptide eye drops of 0.004% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve (0-t) | AUC(0-t) | Within 12hours after administration |
| Area under curve(0-∞) | AUC(0-∞) | Within 12hours after administration |
| Peak concentration | Cmax | Within 12hours after administration |
| Peak time | Tmax | Within 12hours after administration |
| Half life | t1/2 | Within 12hours after administration |
| Apparent volume of distribution | Vd | Within 12hours after administration |
| Elimination rate constant | Kel | Within 12hours after administration |
| Mean residence time | MRT | Within 12hours after administration |
| Clearance | CL or CL/F | Within 12hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiuli Zhao, PHD | Beijing Tongren Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiuli Zhao | Beijing | BJ10 | China |
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