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| ID | Type | Description | Link |
|---|---|---|---|
| P08050 | Other Identifier | Merck |
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This study compares the bioequivalence of omeprazole administered as either Zegerid® powder for oral suspension 20 mg or as Prilosec 40 mg capsule to healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zegerid-Prilosec | Experimental | Participants receive Zegerid in Period 1 and Prilosec in Period 2, with a 10- to 21-day washout between study drug administrations. |
|
| Prilosec-Zegerid | Experimental | Participants receive Prilosec in Period 1 and Zegerid in Period 2, with a 10- to 21-day washout between study drug administrations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omeprazole/sodium bicarbonate | Drug | Single 20 mg dose of omeprazole/sodium bicarbonate powder for oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from 0 to infinity (AUC[0-∞]) | Up to 12 hours post-dose | |
| Maximum plasma concentration (Cmax) | Up to 12 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C494109 | omeprazole, sodium bicarbonate drug combination |
| D013535 | Suspensions |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| omeprazole magnesium | Drug | Single 40 mg capsule of omeprazole given orally |
|
|
| 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 |