Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alprazolam conventional tablet | Active Comparator | Alprazolam conventional tablet |
|
| Alprazolam sublingual tablet | Experimental | Alprazolam sublingual tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprazolam tablet | Drug | 1 mg single dose of alprazolam conventional tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) from time zero to last measurable time of alprazolam | 72 hours | |
| Peak concentration of alprazolam | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time zero to infinity | 72 hours | |
| AUC% extrapolated | 72 hours | |
| Time of Cmax |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Alprazolam sublingual | Drug | 1 mg single dose of alprazolam sublingual tablet |
|
| 72 hours |
| half-life of alprazolam | 72 hours |
| Clinically significant safety laboratory tests | Screening, Day 0, Day 4 |
| Clincally significant vital signs | Screening, Day 4 |
| Clinically significant adverse events | 1 month |
| D006571 | Heterocyclic Compounds |