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Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xanax XR tablets 3 mg (sourced from Caugus) | Active Comparator | Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE) |
|
| Xanax XR tablets 3 mg (sourced from Barceloneta), | Experimental | Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xanax XR tablets 3 mg (sourced from Caugus) | Drug | Tablets, 3 mg, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time zero to infinity (AUCinf) of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose | |
| Peak plasma conc (Cmax) of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from zero to the last time point (AUClast) of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose | |
| Area under the curve extrapolated (AUC%extrap) of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | 188770 | Singapore |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Xanax XR tablets 3 mg (sourced from Barceloneta) | Drug | Tablets, 3 mg, single dose |
|
| Terminal half life of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose |
| Time to peak concentration (Tmax) of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose |
| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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