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A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1 | Experimental | Period 1 : Reference Drug(AD-2131) Period 2 : Test Drug(AD-213-A) |
|
| ARM 2 | Experimental | Period 1 : Test Drug(AD-213-A) Period 2 : Reference Drug(AD-2131) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-213-A | Drug | 1 tablet administered before the breakfast during 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau | Evaluation PK after multiple dose | From Day 1 up to Day 17 |
| Integrated gastric acidity(%Decrease form baseline) | Evaluation PD after multiple dose | 4 times from Day -1 to Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Evaluation PK after single dose | Day 1 |
| AUClast | Evaluation PK after single dose | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | South Korea |
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| AD-2131 |
| Drug |
1 tablet administered before the breakfast during 5 days |
|
| AUCinf | Evaluation PK after single dose | Day 1 |
| Tmax | Evaluation PK after single dose | Day 1 |
| t1/2 | Evaluation PK after single dose | Day 1 |
| CL/F | Evaluation PK after single dose | Day 1 |
| Vd/F | Evaluation PK after single dose | Day 1 |
| Cmax,ss | Evaluation PK after multiple dose | From Day 1 up to Day 17 |
| Cmin,ss | Evaluation PK after multiple dose | From Day 1 up to Day 17 |
| AUCinf | Evaluation PK after multiple dose | From Day 1 up to Day 17 |
| Tmax,ss | Evaluation PK after multiple dose | From Day 1 up to Day 17 |
| t1/2 | Evaluation PK after multiple dose | From Day 1 up to Day 17 |
| CLss/F | Evaluation PK after multiple dose | From Day 1 up to Day 17 |
| Vdss/F | Evaluation PK after multiple dose | From Day 1 up to Day 17 |
| Integrated gastric acidity(Variations form baseline) | Evaluation PD after multiple dose | 4 times from Day -1 to Day 17 |
| Percentage of time to maintain gastric pH 4.0 or higher | Evaluation PD after multiple dose | 4 times from Day -1 to Day 17 |