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A single-center, open-label, parallel-group, phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of LINO-1713 in healthy Korean female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetic evaluation | Experimental | LINO-1713 (Estetrol 15mg/Drospirenone 3mg) |
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| Pharmacodynamic evaluation | Experimental | LINO-1713 (Estetrol 15mg/Drospirenone 3mg) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LINO-1713 1 tablet | Drug | LINO-1713 1 tablet is administered once. Oral administration with 200mL of water |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters: Cmax | Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours | |
| Pharmacokinetics parameters: Tmax | Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | South Korea |
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| LINO-1713 once a day for 24 days | Drug | Oral administration is performed with 200 mL of water. Instruct subjects to take the drug at the same time as possible. |
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