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
A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Drug | Active Comparator |
| |
| Test Drug | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alprazolam tablet | Drug | 0,25 mg oral tablets given once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug | Up to 72h | |
| Area under the plasma concentration versus time curve from time zero to the last measurable concentration of Test Drug and Reference Drug (AUC(0-tlast)) | Up to 72h |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve from time zero to infinity of Test Drug and Reference Drug (AUC(0-inf)) | Up to 72h | |
| Time to peak concentration of Test Drug and Reference Drug (Tmax) | Up to 72h |
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 |
|---|---|---|---|---|---|---|
| ICF - Instituto de Ciencias Farmaceuticas | Aparecida de Goiânia | Goiás | 74935-530 | Brazil |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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 oral solution |
| Drug |
0,75 mg/ml Oral Solution (Drops) given once |
|
| Half-life of Test Drug and Reference Drug (T1/2) | Up to 72h |
| Elimination rate constant (K el) | Up to 72h |
| Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity | Up to 72h |
| D006571 | Heterocyclic Compounds |