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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01330472
First received: April 5, 2011
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Drug: Xanax XR tablets 3 mg (sourced from Caugus)
Drug: Xanax XR tablets 3 mg (sourced from Barceloneta)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area under the curve from time zero to infinity (AUCinf) of alprazolam [ Time Frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose ] [ Designated as safety issue: No ]
  • Peak plasma conc (Cmax) of alprazolam [ Time Frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve from zero to the last time point (AUClast) of alprazolam [ Time Frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose ] [ Designated as safety issue: No ]
  • Area under the curve extrapolated (AUC%extrap) of alprazolam [ Time Frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose ] [ Designated as safety issue: No ]
  • Terminal half life of alprazolam [ Time Frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose ] [ Designated as safety issue: No ]
  • Time to peak concentration (Tmax) of alprazolam [ Time Frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Xanax XR tablets 3 mg (sourced from Caugus)
Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE)
Drug: Xanax XR tablets 3 mg (sourced from Caugus)
Tablets, 3 mg, single dose
Experimental: Xanax XR tablets 3 mg (sourced from Barceloneta),
Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST)
Drug: Xanax XR tablets 3 mg (sourced from Barceloneta)
Tablets, 3 mg, single dose

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330472

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01330472     History of Changes
Other Study ID Numbers: A6131025
Study First Received: April 5, 2011
Last Updated: May 22, 2012
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:
Alprazolam
Xanax
Bioequivalence
Panic disorder with or without agoraphobia.

Additional relevant MeSH terms:
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014