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An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual Tablets in Healthy Adult Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Lafutidine and Irsogladine maleate --> BRI-1501) | Other | Subjects of Arm A take Lafutidine and Irsogladine maleate Individual tablets at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm A take a BRI-1501 tablet at 36th day |
|
| Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate) | Other | Subjects of Arm B take a BRI-1501 tablet at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm B take Lafutidine and Irsogladine maleate Individual tablets at 36th day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRI-1501 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate | 0~36 hour after medication | |
| Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate | 0~36 hour after medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Seoul St.Mary's Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C076948 | lafutidine |
| C041836 | irsogladine |
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| Lafutidine |
| Drug |
|
| Irsogladine maleate | Drug |
|
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |