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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
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.
Show details

- 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.

NCT01330472
Pfizer
Completed
An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites

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1-800-718-1021

[email protected]

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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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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