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This is a randomized, open label, multiple dose, crossover study to compare the safety and Pharmacokinetics (PKs) between two rebamipide formulations after multiple oral doses of "rebamipide SR 150 mg" and "rebamipide IR 100 mg" in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A (RT) | Other | [Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
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| Sequence B (TR) | Other | [Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebamipide SR 150mg | Drug | Test drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak Plasma Concentration of Rebamipide | From Period1/ Day1 to Period2/Day9 |
| AUClast of Rebamipide | Area Under the plasma concentration versus time curve last of Rebamipide | From Period1/ Day1 to Period2/Day9 |
| Measure | Description | Time Frame |
|---|---|---|
| t1/2 β of Rebamipide | Time taken for half the initial dose of Rebamipide administered to be eliminated from the body | From Period1/ Day1 to Period2/Day9 |
| Tmax of Rebamipide | Time at which the Cmax of Rebamipide is observed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
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| Rebamipide IR 100mg |
| Drug |
Reference Drug |
|
| From Period1/ Day1 to Period2/Day9 |
| AUCinf of Rebamipide | Area Under the plasma concentration versus time curve inifinite of Rebamipide | From Period1/ Day1 to Period2/Day9 |