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Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male or female subjects

- BMI 17.5 - 30.5

- Must provide informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Clinically significant disease

- Narrow angle glaucoma

- Positive drug screen

NCT00877955
Pfizer
Withdrawn
Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation

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Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation
Open-label, Randomized, Single-dose, 2-way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Sublingual Tablet
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: alprazolam sublingual tablet commercial
    0.5 mg sublingual tablet, single dose
  • Drug: alprazolam sublingual tablet test
    0.5 mg tablet, single dose
  • Active Comparator: alprazolam sublingual tablet reference
    Intervention: Drug: alprazolam sublingual tablet commercial
  • Experimental: alprazolam sublingual tablet test
    Intervention: Drug: alprazolam sublingual tablet test
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female subjects
  • BMI 17.5 - 30.5
  • Must provide informed consent

Exclusion Criteria:

  • Clinically significant disease
  • Narrow angle glaucoma
  • Positive drug screen
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00877955
A6131019
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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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.

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1-800-718-1021

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[email protected]



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