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Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A (RT) | Experimental | Period 1: Reference (PA-111A), Period 2: Test (PA-111) |
|
| Sequence A (TR) | Experimental | Period 1: Test (PA-111), Period 2: Reference (PA-111A), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA-111 | Drug | PA-111 1Tab., Per Oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of drug in plasma (Cmax) | Cmax of PA-111 | pre-dose (0hour) to 72hours |
| Area under the plasma concentration-time curve during dosing interval (AUCt) | AUCt of PA-111 | pre-dose (0hour) to 72hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JeongEun Park | Contact | +82-31-891-6989 | parkje@addpharma.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Recruiting | Seoul | South Korea |
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| PA-111A |
| Drug |
PA-111A 1Capsule., Per Oral |
|