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The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder and Losec 20mg capsules in healthy volunteers under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zegerid 20mg capsule | Active Comparator | Zegerid 20mg capsule (20mg omeprazole and 1100mg sodium carbonate |
|
| Zegerid 20mg powder for oral suspension | Active Comparator | Zegerid 20mg powder for oral suspension (20mg omeprazole and 1680mg sodium bicarbonate) |
|
| Losec 20mg capsule | Active Comparator | Losec 20mg capsule (20mg omeprazole) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zegerid | Drug |
| ||
| Losec |
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability - Area under Curve of pH at 2 hours | To assess the relative bioavailability of two immediate release formulations of omeprazole/sodium carbonate (Zegerid 20mg capsule and Zegerid 20mg powder for oral suspension) | 2 hours |
| Pharmacodynamics - Area under Curve of pH at 2 hours | To assess the relative pharmacodynamic profiles of two immediate release formulations of omeprazole/sodium bicarbonate (Zegerid® 20mg capsule and Zegerid® 20mg powder for oral suspension). | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of study formulations using measurements of Cmax, tmax and t1/2 | To assess the safety and tolerability of these three formulations after single dose oral administration. To include measurements of Cmax, tmax and t1/2 | pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome Hanna, MB BCH MRCS | Bio-Kinetic Europe, Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Kinetic Europe Limited, 14 Great Victoria Street, Belfast BT2 7BA | Belfast | BT2 7BA | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 13, 2013 | |
| Reset | Mar 15, 2013 | |
| Release | Jun 3, 2013 |
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| Drug |
|
| Bioavailability - measurement of pH over time | To assess the relative bioavailability of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg capsule) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. AUC of pH and % of time for pH to raise above 4 (0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours) | 0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours |
| Bioavailability - measurement of pH over time | To assess the relative bioavailability of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg powder for oral suspension) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. AUC of pH and % of time for pH to raise above 4 (0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours) | 0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours |
| Pharmacodynamic Measurements of Cmax, Tmax and t1/2 | To assess the relative pharmacodynamic profiles of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg capsule) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. | Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose |
| Pharmacodynamic measurements of Cmax, Tmax and t1/2 | To assess the relative pharmacodynamic profiles of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg powder for oral suspension) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state | Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose |
| Reset | Aug 27, 2013 |
| Release | Sep 10, 2024 |
| Reset | Nov 15, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 13, 2013 | Mar 15, 2013 | |||
| Jun 3, 2013 | Aug 27, 2013 | |||
| Sep 10, 2024 | Nov 15, 2024 |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C494109 | omeprazole, sodium bicarbonate drug combination |
| D009853 | Omeprazole |
| 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 |
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