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Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

Last updated on November 21, 2019

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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Withdrawn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

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Descriptive Information
Brief Title  ICMJE Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation
Official Title  ICMJE Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet
Brief SummaryThis study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.
Detailed DescriptionNot 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
Intervention  ICMJE
  • Drug: alprazolam commercial sublingual formulation
    0.5 mg tablet, single dose
  • Drug: alprazolam test sublingual tablet
    0.5 mg tablet, single dose
Study Arms  ICMJE
  • Active Comparator: Alprazolam commercial sublingual tablet
    Intervention: Drug: alprazolam commercial sublingual formulation
  • Experimental: Alprazolam test sublingual tablet
    Intervention: Drug: alprazolam test sublingual tablet
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Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 1, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2011)
26
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion DateJune 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01285505
Other Study ID Numbers  ICMJE A6131020
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2018

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 the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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