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

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ClinicalTrials.gov Identifier: NCT01330472
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : May 24, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330472


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01330472     History of Changes
Other Study ID Numbers: A6131025
First Posted: April 7, 2011    Key Record Dates
Last Update Posted: May 24, 2012
Last Verified: May 2012

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
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action