An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites

Study Overview
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Brief Summary
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Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.

Official Title
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An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Xanax XR Tablet 3 mg (Sourced From Caguas) Versus Xanax XR Tablet 3 mg (Sourced From Barceloneta) In Healthy Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Xanax XR tablets 3 mg (sourced from Caugus)
* Drug: Xanax XR tablets 3 mg (sourced from Barceloneta)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 20 and 55 years, inclusive. An informed consent document signed and dated by the subject. Exclusion Criteria: Evidence or history of clinically significant abnormality. A positive urine drug screen. Subjects who are hypersensitive to alprazolam or related compounds.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xanax XR tablets 3 mg (sourced from Caugus)<br>Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE) | Drug: Xanax XR tablets 3 mg (sourced from Caugus)<br>* Tablets, 3 mg, single dose<br>|
| Experimental: Xanax XR tablets 3 mg (sourced from Barceloneta),<br>Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST) | Drug: Xanax XR tablets 3 mg (sourced from Barceloneta)<br>* Tablets, 3 mg, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alprazolam, Xanax, Bioequivalence, Panic disorder with or without agoraphobia.