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Bioequivalence of Alprazolam Sublingual vs Oral Tablets

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NCT00860119

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 015 India
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
21-55 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

NCT00860119
Pfizer
Completed
Bioequivalence of Alprazolam Sublingual vs Oral Tablets

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Pfizer Clinical Trials Contact Center

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[email protected]

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Bioequivalence of Alprazolam Sublingual vs Oral Tablets
Open-Label, Randomized, Single-Dose, 2-Way Crossover Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: alprazolam sublingual tablet
    1 mg alprazolam sublingual tablet, given as a single dose to each subject
  • Drug: alprazolam oral tablet
    1 mg alprazolam immediate release oral tablet, given as a single dose to each subject
    Other Name: Xanax
  • Experimental: Sublingual tablet
    Test treatment
    Intervention: Drug: alprazolam sublingual tablet
  • Experimental: Oral tablet
    Reference treatment
    Intervention: Drug: alprazolam oral tablet
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
October 2009
October 2009   (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
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00860119
A6131017
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2009

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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