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The Objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-released tablets (manufactured by TEVA Pharmaceutical Industries,Ltd. and distributed by TEVA Pharmaceuticals USA)with that of PROTONIX® 40mg delayed-released tablets (Wyeth- Ayerst) in Healthy, adult, non-smoking subjects under non- fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole Sodium 40 mg delayed-release tablets | Drug | 1 x 40 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on Cmax and AUC | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Herrmann, M.D.; Ph.D | Cetero Research, San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gateway Medical Research, Inc. | Saint Charles | Missouri | 63301 | United States | ||
| Bioassay Laboratory, Inc. |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 2, 2009 | |
| Reset | Aug 17, 2009 | |
| Release | Sep 11, 2009 | |
| Reset | Oct 14, 2009 | |
| Release | Aug 19, 2024 | |
| Reset | Oct 30, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 2, 2009 | Aug 17, 2009 | |||
| Sep 11, 2009 |
| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| PROTONIX® 40 mg delayed-release tablets. |
| Drug |
1 x 40 mg |
|
| Houston |
| Texas |
| 77099 |
| United States |
| Oct 14, 2009 |
| Aug 19, 2024 | Oct 30, 2024 |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |