You are here

Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

Last updated on May 10, 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 18 to 26.9

- must give 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

NCT01285505
Pfizer
Withdrawn
Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation
Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet
This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: alprazolam commercial sublingual formulation
    0.5 mg tablet, single dose
  • Drug: alprazolam test sublingual tablet
    0.5 mg tablet, single dose
  • Active Comparator: Alprazolam commercial sublingual tablet
    Intervention: Drug: alprazolam commercial sublingual formulation
  • Experimental: Alprazolam test sublingual tablet
    Intervention: Drug: alprazolam test sublingual tablet
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
26
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy male or female subjects
  • BMI 18 to 26.9
  • must give 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
 
 
NCT01285505
A6131020
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

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]



Call Now