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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330472
First Posted: April 7, 2011
Last Update Posted: May 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
April 5, 2011
April 7, 2011
May 24, 2012
May 2011
June 2011   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Same as current
Complete list of historical versions of study NCT01330472 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites
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 to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Subjects
  • Drug: Xanax XR tablets 3 mg (sourced from Caugus)
    Tablets, 3 mg, single dose
  • Drug: Xanax XR tablets 3 mg (sourced from Barceloneta)
    Tablets, 3 mg, single dose
  • Active Comparator: Xanax XR tablets 3 mg (sourced from Caugus)
    Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE)
    Intervention: Drug: Xanax XR tablets 3 mg (sourced from Caugus)
  • Experimental: Xanax XR tablets 3 mg (sourced from Barceloneta),
    Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST)
    Intervention: Drug: Xanax XR tablets 3 mg (sourced from Barceloneta)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2011
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01330472
A6131025
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP