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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Xanax XR tablets 3 mg (sourced from Caugus); Drug: Xanax XR tablets 3 mg (sourced from Barceloneta)

• Registration Number: NCT01330472
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-07
• Study Start: 2011-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Xanax XR tablets 3 mg (sourced from Caugus)	Xanax XR tablets 3 mg (sourced from Caugus)	Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE)
Xanax XR tablets 3 mg (sourced from Barceloneta),	Xanax XR tablets 3 mg (sourced from Barceloneta)	Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore