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Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-120 compared with AD-120A in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm-A | Experimental | Period 1 : Test Drug (AD-120), Period 2 : Reference Drug (AD-120A) |
|
| Arm-B | Experimental | Period 1 : Reference Drug (AD-120A), Period 2 : Test Drug (AD-120) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-120A | Drug | Administered before the breakfast during 7 days, Oral, Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve over a dosing interval at steady state (AUCÏ„,ss) | AUCÏ„,ss after 7days repeated administration of Omeprazole | AUCÏ„,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days) |
| The time of peak concentration after single dose | Tmax after 1days administration of Omeprazole | Tmax: from pre-dose to 24 hours of 1st administration |
| Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring | Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring for 24-hour interval after 7th dose | 24 hours before 1st administration to 24 hours after repeated administration (7days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Yang | Contact | +82-31-891-6918 | hnyang@addpharma.co.kr | |
| Seung Hwan Lee, M.D., Ph.D. | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| AD-120 | Drug | Administered before the breakfast during 7 days, Oral, Tablet |
|
|
| D004066 | Digestive System Diseases |