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Clinical Trial to Assess the PK/PD of YYD601 20mg After Oral Administration if Healthy Adult Subjects (Phase1)
To evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 20mg and Nexium tab 20mg and the effects of food influence the PK/PD of YYD601 20mg in a healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YYD601 20mg | Experimental | Esomeprazole IR 10mg + esomeprazole SR 10mg |
|
| Nexium tab 20mg | Active Comparator | Esomeprazole magnesium trihydrate 22.3mg. Astrazeneca |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YYD601 20mg | Drug | Esomeprazole IR 10mg + Esomeprazole SR 10mg (Expected efficacy and effects: GERD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Cmax after single administration and repeated administration | Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day |
| AUC | AUC after single administration and repeated administration | Integrated gastric acidity: Stomach acid test (24pH) on 1 day, 5 day, 11 day, 16 day |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | AUC after single administration and repeated administration | pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day |
| Tmax |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39803609 | Derived | Lee HW, Kang WY, Park JS, Lee JH, Park JJ, Gwon MR, Yoon YR, Seong SJ. A Pharmacokinetic/Pharmacodynamic Study of Esomeprazole Comparing a Dual Delayed-Release Formulation (YYD601) to a Conventional Formulation Following Multiple Administrations in Healthy Adult Subjects. Drug Des Devel Ther. 2025 Jan 8;19:97-110. doi: 10.2147/DDDT.S500253. eCollection 2025. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D015507 | Drugs, Investigational |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
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| Nexium tab 20mg | Drug | Esomeprazole magnesium trihydrate 22.3mg Effecacy and Effects: GERD and Antibiotics combined therapy to eradicate the Helicobacter pylori |
|
|
Tmax after single administration and repeated administration
| pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day |
| t1/2 | t1/2 after single administration and repeated administration | pH>4(%): stomach acid test(24pH) on -1 day, 5 day, 11 day, 16 day and change in serum gastrin level on -1 day, 1day, 5 day |
| D004066 | Digestive System Diseases |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |