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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Subjects

Intervention: Xanax XR tablets 3 mg (sourced from Caugus) (Drug); Xanax XR tablets 3 mg (sourced from Barceloneta) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area under the curve from time zero to infinity (AUCinf) of alprazolam

Peak plasma conc (Cmax) of alprazolam

Secondary outcome:

Area under the curve from zero to the last time point (AUClast) of alprazolam

Area under the curve extrapolated (AUC%extrap) of alprazolam

Terminal half life of alprazolam

Time to peak concentration (Tmax) of alprazolam

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2011
Last updated: May 22, 2012

Page last updated: August 23, 2015

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