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This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E3810 | Drug | RAB ER 50 mg capsule once per day on Days 1-5 |
| |
| Aciphex (rabeprazole) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time that intragastric pH remains >4 | 24-hr period post-dose on Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of day- and night-time periods with intragastric pH >4 | Days 1 and 5 | |
| Number and duration of nocturnal acid breakthrough (NAB) episodes | Days 1 and 5 | |
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Key inclusion:
Key Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Miner | Oklahoma Foundation for Digestive Research, 1000 N. Lincoln, Suite 210, Oklahoma City, OK 73104 USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73104 | United States |
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| Drug |
Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5 |
|
| Nexium (esomeprazole) | Drug | Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5 |
|
| Proportion of subjects with nocturnal acid breakthrough (NAB) episodes |
| Days 1 and 5 |
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| 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 |
| D009853 | Omeprazole |
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