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Xanax

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01330472An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing SitesPHASE1 COMPLETED 16May 1, 2011Jun 1, 2011Jan 28, 20211 Singapore
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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 — 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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