Approval Probability
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Label indication Alprazolam XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam XR is a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. ( 1 ) FDA label
Alprazolam · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Alprazolam | EXPERIMENTAL | Alprazolam 3mg 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 (reference) dosed in first period followed by Alprazolam 3 mg ER Tablet (test) dosed in second period |
| 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 |
| Name | Type | Description |
|---|---|---|
| Alprazolam Extended-Release 3 mg Tablets | DRUG | 1 x 3 mg, single dose fasting |
Inclusion Criteria: * Screening Demographics: All subjects selected for this study will be healthy non-smoking men and women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30. * Screening procedures: Each subject will complete the...
Alprazolam is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is being studied in Phase 1 clinical trials. The specific medical conditions it is intended to treat have not been disclosed. Alprazolam is also known as Alprazolam Extended-Release 3 mg Tablets.
Alprazolam targets the GABRA1, GABRB2, GABRG2, GABRB3, GABRA4, and GABRG3 subunits. It acts as a positive allosteric modulator of these targets. This mechanism is characteristic of its target class, which involves modulation of GABA receptor activity.
Alprazolam is developed by Teva Pharmaceutical Industries Limited, a company that trades under the ticker symbol TEVA. Teva is responsible for the clinical development of this drug candidate.
Alprazolam is in Phase 1 of clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trials for Alprazolam have been completed, and there are currently no active trials.
Alprazolam has been studied in two completed Phase 1 clinical trials: NCT00830024 and NCT00829426. Both trials were bioequivalence studies of Alprazolam Extended-Release 3 mg tablets, conducted under non-fasting and fasting conditions, respectively, in healthy volunteers in the United States.