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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
History of Changes
  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:

Drug Information available for: Alprazolam
U.S. FDA Resources

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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 June 18, 2013