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This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA with that of 3 mg XANAX XR® Tablets by Pharmacia & Upjohn Company following a single oral dose (1 x 3 mg extended release tablet) in healthy adult subjects administered 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 |
|---|---|---|---|
| Alprazolam (test) | Experimental | Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period |
|
| Xanax XR® | Active Comparator | Xanax XR® 3 mg Tablet (test) dosed in first period followed by Alprazolam 3 mg ER Tablet (test) dosed in second period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprazolam Extended-Release 3 mg Tablets | Drug | 1 x 3 mg, single dose non-fasting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Concentration | Bioequivalence based on Cmax | Blood samples collected over 72 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 72 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 72 hour period |
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Inclusion Criteria:
The screening clinical laboratory procedures will include:
If female and:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James D. Carlson, Pharm. D. | PRACS Institute, Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRACS Institute, Ltd. | East Grand Forks | Minnesota | 56721 | United States | ||
| PRACS Institute, Ltd. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test First | Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period |
| FG001 | Reference First | Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout: 7 Days |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test First | Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period |
| BG001 | 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 | Bioequivalence based on Cmax | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jun 2009 | Mean | Standard Deviation | ng/mL | Blood samples collected over 72 hour period |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manger, Biopharmaceutics | Teva Pharmaceuticals USA | 1-866-384-5525 | clinicaltrialqueries@tevausa.com |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Alprazolam Extended-Release 3 mg Tablets |
| Drug |
1 x 3 mg, single dose non-fasting |
|
|
| Fargo |
| North Dakota |
| 58104 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product 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. | Posted | Jun 2009 | Mean | Standard Deviation | ng*h/mL | Blood samples collected over 72 hour period |
|
|
|
|
| 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 | May 2009 | Mean | Standard Deviation | ng*h/mL | Blood samples collected over 72 hour period |
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Principal Investigator is not permitted to discuss or publish trial results.
| D006571 | Heterocyclic Compounds |