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NCT01330472 Clinical Trial

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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01330472
Other study ID # A6131025
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2011
Est. completion date June 2011

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Xanax XR tablets 3 mg (sourced from Caugus)
Tablets, 3 mg, single dose
• Xanax XR tablets 3 mg (sourced from Barceloneta)
Tablets, 3 mg, single dose

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary Terminal half life of alprazolam Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Secondary 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
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