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

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01330472

A6131025

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Xanax XR tablets 3 mg (sourced from Caugus)

Active Comparator group

Description:

Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE)

Treatment:

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

Xanax XR tablets 3 mg (sourced from Barceloneta),

Experimental group

Description:

Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST)

Treatment:

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