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To evaluate drug-drug interaction
The main objective is to evaluate the pharmacokinetic profile of the 50mg Revaprazan plus 50mg Itopride compared to 50mg Revaprazan or 50mg Itopride alone in healthy Korean subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
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| Sequence 2 | Experimental |
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| Sequence 3 | Experimental |
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| Sequence 4 | Experimental |
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| Sequence 5 | Experimental |
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| Sequence 6 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequence 1 | Other | Period1(A) Period2(B) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis. | Blood sampling will be obtained on day 7 at each period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASAN Medical Center, University of Ulsan | Seoul | South Korea |
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| Sequence 2 | Other | Period1(C) Period2(A) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) |
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| Sequence 3 | Other | Period1(B) Period2(C) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) |
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| Sequence 4 | Other | Period1(C) Period2(B) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) |
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| Sequence 5 | Other | Period1(B) Period2(A) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) |
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| Sequence 6 | Other | Period1(A) Period2(C) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) |
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