Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bicarbonate · 1 trial · 2 indications
The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.
| Arm | Type | Description |
|---|---|---|
| Single Dose Zegerid for 1 or 7 days | EXPERIMENTAL | Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension |
| Single Dose Prilosec 1 or 7 days | ACTIVE_COMPARATOR | Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet |
| Sodium Bicarbonate | ACTIVE_COMPARATOR | Sodium Bicarbonate 1680 mg Oral Suspension |
| Name | Type | Description |
|---|---|---|
| Omeprazole/sodium bicarbonate | DRUG | Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days. |
| omeprazole magnesium | DRUG | Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days. |
| sodium bicarbonate | DRUG | Sodium bicarbonate. Single dose. |
Inclusion Criteria: * Normal subjects who are 18-65 years of age. * Non-childbearing potential females or those using birth control. Exclusion Criteria: * History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors * History of significant gastrointestinal di...
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