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A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Tegoprazan (C1) | Experimental | Tegoprazan QD, oral administration |
|
| Treatment B: Tegoprazan (C1) | Experimental | Tegoprazan QD, oral administration |
|
| Treatment C: Tegoprazan (C1) | Experimental | Tegoprazan BID, oral administration |
|
| Group 1: Tegoprazan (C2) | Experimental | Tegoprazan QD, oral administration, for 7 days |
|
| Group 2: Tegoprazan (C2) | Experimental | Tegoprazan QD, oral administration, for 7 days |
|
| Group 3: Esomeprazole (C2) | Active Comparator | Esomeprazole QD, oral administration, for 7 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan (C1) | Drug | Tegoprazan QD, oral administration. Treatment A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-24h) of tegoprazan | Area Under the Curve(0-24h) of tegoprazan | up to 7 days |
| Cmax of tegoprazan | Maximum Plasma Concentration of tegoprazan | up to 7 days |
| Gastric pH | Gastric pH | up to 7 days |
| Serum gastrin concentration | Serum gastrin concentration | up to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| In Jin Jang, MD, PhD | Contact | 82-2-2072-1666 | ijjang@snu.ac.kr | |
| Mu Seong Ban, MD | Contact | 82-2-2072-1666 | ban2699@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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Cohort 1: crossover Cohort 2: parallel Cohort 3: single group
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| Tegoprazan (C3) | Experimental | Tegoprazan QD, oral administration |
|
| Tegoprazan (C1) |
| Drug |
Tegoprazan QD, oral administration. Treatment B |
|
| Treatment C: Tegoprazan (C1) | Drug | Tegoprazan BID, oral administration |
|
| Tegoprazan (C2) | Drug | Tegoprazan QD, oral administration, for 7 days. Group 1 |
|
| Tegoprazan (C2) | Drug | Tegoprazan QD, oral administration, for 7 days. Group 2 |
|
| Esomeprazole (C2) | Drug | Esomeprazole QD, oral administration, for 7 days. Group 3 |
|
| Tegoprazan (C3) | Drug | Tegoprazan QD, oral administration |
|
| 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 |