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This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alprazolam commercial sublingual tablet | Active Comparator |
| |
| Alprazolam test sublingual tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alprazolam commercial sublingual formulation | Drug | 0.5 mg tablet, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC) | 11 days | |
| Alprazolam bioavailability as assessed by peak concentration (Cmax) | 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Alprazolam time of maximum concentration (Tmax) | 11 days | |
| Half life of alprazolam | 11 days | |
| Clinically significant safety laboratory tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| alprazolam test sublingual tablet | Drug | 0.5 mg tablet, single dose |
|
| 11 days |
| Clinically significant adverse events | 11 days |
| Clinically significant vital signs | 11 days |