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Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-212-A compared with AD-2121 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm-A | Experimental | Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A) |
|
| Arm-B | Experimental | Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole 15 mg | Drug | AD-2121 (Lansoprazole 15 mg), Oral, Capsule |
| |
| 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 Lansoprazole | pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days) |
| Percent Decrease from baseline of Integrated gastric acidity | Percent Decrease from baseline of Integrated gastric acidity after repeated adadministration of Lansoprazole Integrated gastric acidity calculation: (Integrated gastric acidity Before - Integrated gastric acidity after)/Integrated gastric acidity Before*100
| 24 hours before 1st administration to 24 hours after repeated administration (7days) |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|
| D064747 | Lansoprazole |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Lansoprazole 15mg/Calcium carbonate 600mg |
| Drug |
AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet |
|
| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |