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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

April 5, 2011
May 22, 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 ] [ 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 ]
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 ] [ 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 ]
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.
Both
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01330472
A6131025
No
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