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The objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PROTONIX® 40 mg delayed-released tablets (Wyeth-Ayerst) in Healthy, adult, non-smoking subjects under fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pantoprazole | Experimental | Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period |
|
| Protonix® | Active Comparator | Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole Sodium 40 mg delayed-release tablets | Drug | 1 x 40 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Concentration - Pantoprazole in Plasma | Bioequivalence based on Cmax | Blood samples collected over 16 hour period |
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Bioequivalence based on AUC0-inf | Blood samples collected over 16 hour period |
| AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | Bioequivalence based on AUC0-t | Blood samples collected over 16 hour period |
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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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pantoprazole (Test) First | Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period |
| FG001 | Protonix® (Reference) First | Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout: 5 Days |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pantoprazole (Test) First | Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period |
| BG001 | Protonix® (Reference) First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax - Maximum Observed Concentration - Pantoprazole in Plasma | Bioequivalence based on Cmax | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jul 2009 | Mean | Standard Deviation | ng/mL | Blood samples collected over 16 hour period |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Biopharmaceutics | Teva Pharmaceuticals USA | 1-866-384-5525 | clinicaltrialqueries@tevausa.com |
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| 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 |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Bioequivalence based on AUC0-inf | Data from all subjects who completed the study were included in the statistical analysis. Not all subjects data could be used to estimate AUC0-inf. | Posted | Jul 2009 | Mean | Standard Deviation | ng*h/mL | Blood samples collected over 16 hour period |
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|
| Primary | AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | Bioequivalence based on AUC0-t | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jul 2009 | Mean | Standard Deviation | ng*h/mL | Blood samples collected over 16 hour period |
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Principal Investigator is not permitted to discuss or publish trial results.
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |