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

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NCT01330472

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Study Location
Pfizer Investigational Site
Singapore, , 188770, Singapore
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence or history of clinically significant abnormality.


- A positive urine drug screen.


- Subjects who are hypersensitive to alprazolam or related compounds.

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Advanced Information
Descriptive Information
Brief Title  ICMJE An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites
Official Title  ICMJE 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
Brief Summary Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2011)		16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01330472
Other Study ID Numbers  ICMJE A6131025
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

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