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Label indication Omeprazole and Sodium Bicarbonate for oral suspension and Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the : short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. FDA label
Omeprazole · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Omeprazole Magnesium DR 20 mg Capsules | EXPERIMENTAL | Omeprazole Magnesium DR 20 mg Capsules of Dr Reddys Laboratories Limited |
| Prilosec 20 mg Tablets | ACTIVE_COMPARATOR | Prilosec 20 mg Tablets of Procter and Gamble |
| Omeprazole | EXPERIMENTAL | Omeprazole Delayed Release Capsules of Dr. Reddy's Laboratories Limited |
| Prilosec | ACTIVE_COMPARATOR | Prilosec® 40 mg Merck \& Co. Inc |
| Name | Type | Description |
|---|---|---|
| Omeprazole | DRUG | Omeprazole Magnesium DR 20 mg Capsules |
| Prilosec® 40 mg | DEVICE | Prilosec® 40 mg |
| Prilosec | DRUG | Prilosec® 40 mg of Merck \& Co.Inc. |
Inclusion Criteria: * Healthy human subjects within the age range of 18 to 45 years. * Non-smokers since at least six months. * Willingness to provide written informed consent to participate in the study. * Body-mass index of ≥18.5 kg/m2 and≤ 24.9 kglm2, with body weight not less than 50 kg. * Abse...
Omeprazole is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed, and the therapeutic area is classified as other. It is a generic-style bioequivalence candidate rather than a novel chemical entity.
Omeprazole targets ATP4A and ATP4B. It acts as an inhibitor of these targets. ATP4A and ATP4B form the gastric proton pump, the enzyme complex responsible for acid secretion in the stomach. Inhibiting this pump reduces gastric acid production.
Omeprazole is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical program described here. Dr. Reddy's is an established pharmaceutical manufacturer, and this asset is being advanced through its own development pipeline.
Omeprazole is in Phase 1 clinical development. All four of its registered trials are Phase 1 studies, and all four have been completed. No active trials are currently listed for this program. It is an investigational asset and has not been described as approved in this program.
Four completed Phase 1 trials are registered for Omeprazole: NCT01170182, NCT01170169, NCT01045642, and NCT01045434. Total enrollment across these studies was 198 participants. The trials were randomized and active controlled, and they enrolled healthy adult volunteers, including studies conducted under both fed and fasting conditions.
Yes. All four registered Omeprazole trials are bioequivalence studies of delayed release capsules, comparing Dr. Reddy's formulations under fed and fasting conditions. NCT01170182 and NCT01170169 evaluated omeprazole delayed release capsules, while NCT01045642 and NCT01045434 evaluated omeprazole magnesium 20 mg delayed release capsules. Two of the studies were conducted in India.