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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01330472

Enrollment

Registered

2011-04-07

Start date

2011-05-31

Completion date

2011-06-30

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Alprazolam, Xanax, Bioequivalence, Panic disorder with or without agoraphobia.

Brief summary

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

Interventions

DRUGXanax XR tablets 3 mg (sourced from Caugus)

Tablets, 3 mg, single dose

DRUGXanax XR tablets 3 mg (sourced from Barceloneta)

Tablets, 3 mg, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026