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The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.
A randomized, open-label, single-dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of AD-115A and the administration of AD-1151 for healthy subjects in fasting state
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1 : Reference Drug(Rebanex Tab), Period 2 : Test Drug(Revaprazan sulfate) Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2. |
|
| Sequence B | Experimental | Period 1 : Test Drug(Revaprazan sulfate), Period 2 : Reference Drug(Rebanex Tab) Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-115A, AD-1151 | Drug | Single-dose oral administration of AD-115A or AD-1151 (200 mg tablet), according to randomized sequence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of drug in plasma (Cmax) | Cmax of AD-115A | pre-dose to 24 hours |
| Area under the plasma concentration-time curve during dosing interval (AUCt) | AUCt of AD-115A | pre-dose to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JaeHun Jung | Contact | +82-31-891-5683 | jhjung@addpharma.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H PLUS YANGJI HOSPITAL, Seoul | Recruiting | 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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| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |