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This is a randomized, open-label, single-dose, 4-way crossover phase 1 study to evaluate the food effect on pharmacokinetics of DA-8010 after a single administration of DA-8010 2.5 mg or 5 mg under fasting and fed states in healthy male and female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1 | Experimental | DA-8010 2.5 mg (Fasting) |
|
| T2 | Experimental | DA-8010 2.5 mg (Fed) |
|
| T3 | Experimental | DA-8010 5 mg (Fasting) |
|
| T4 | Experimental | DA-8010 5 mg (Fed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-8010 2.5mg (Fasting) | Drug | Test drug l : DA-8010 2.5mg (Fasting) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | PK parameter | 0~48hours |
| Area under the plasma concentration versus time curve (AUClast) | PK parameter | 0~48hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung Hwan Lee, PhD | SNUH Clinical Pharmacololgy and Therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Soeul | South Korea |
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| DA-8010 2.5mg (Fed) |
| Drug |
Test drug ll : DA-8010 2.5mg (Fed) |
|
| DA-8010 5mg (Fasting) | Drug | Test drug llI : DA-8010 5mg (Fasting) |
|
| DA-8010 5mg (Fed) | Drug | Test drug lV : DA-8010 5mg (Fed) |
|
| ID | Term |
|---|---|
| C000630740 | DA-8010 |
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