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Xanax

Phase 1

Healthy Subjects | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 28, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Xanax · 1 trial · 1 indication

Phase 1 1
NCT01330472An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing SitesHealthy Subjects
COMPLETED16 Analytics
PHASE1COMPLETED
An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Xanax XR tablets 3 mg (sourced from Caugus)ACTIVE_COMPARATORXanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE)
Xanax XR tablets 3 mg (sourced from Barceloneta),EXPERIMENTALXanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST)

Interventions

NameTypeDescription
Xanax XR tablets 3 mg (sourced from Caugus)DRUGTablets, 3 mg, single dose
Xanax XR tablets 3 mg (sourced from Barceloneta)DRUGTablets, 3 mg, single dose
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Eligibility Criteria

Age Range20 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Singapore
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Frequently asked questions about Xanax

What is Xanax used for in healthy subjects?

Xanax is an investigational small molecule being studied in healthy subjects. A completed Phase 1 bioequivalence study evaluated Xanax extended release tablets from two different manufacturing sites. The study enrolled 16 participants in Singapore, with a minimum age of 20 years.

Who makes Xanax?

Xanax is being developed by Pfizer, Inc., which trades under the ticker PFE. The company conducted a Phase 1 clinical trial of the drug in healthy subjects.

What phase is Xanax in?

Xanax is in Phase 1 clinical development. One Phase 1 study has been completed, and there are no active trials currently listed. The drug remains investigational and is not approved.

What clinical trials is Xanax in?

Xanax has one completed clinical trial, NCT01330472, titled 'An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites.' This Phase 1 study enrolled 16 healthy subjects in Singapore and was active-controlled.

Is Xanax the same as alprazolam?

Xanax is the brand name for alprazolam, a small molecule. The clinical trial NCT01330472 studied Xanax extended release tablets, comparing tablets from two manufacturing sites for bioequivalence.