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Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

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ClinicalTrials.gov Identifier: NCT01256151
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : May 26, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 6, 2010
First Posted Date  ICMJE December 8, 2010
Last Update Posted Date May 26, 2011
Study Start Date  ICMJE January 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2010)
  • Area under the curve (AUC) from time zero to last measurable time of alprazolam [ Time Frame: 72 hours ]
  • Peak concentration of alprazolam [ Time Frame: 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01256151 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
  • Area under the curve from time zero to infinity [ Time Frame: 72 hours ]
  • AUC% extrapolated [ Time Frame: 72 hours ]
  • Time of Cmax [ Time Frame: 72 hours ]
  • half-life of alprazolam [ Time Frame: 72 hours ]
  • Clinically significant safety laboratory tests [ Time Frame: Screening, Day 0, Day 4 ]
  • Clincally significant vital signs [ Time Frame: Screening, Day 4 ]
  • Clinically significant adverse events [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2010)
  • Area under the curve from time zero to infinity [ Time Frame: 72 hours ]
  • AUC% extrapolated [ Time Frame: 72 hours ]
  • Time of Cmax [ Time Frame: 72 hours ]
  • half-life of alprazolam [ Time Frame: 72 hours ]
  • Clinically significant safety laboratory tests [ Time Frame: Screening, Day 0, Day 4 ]
  • Clinically significant vital signs [ Time Frame: Screening, Day 4 ]
  • Clinically significant adverse events [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet
Official Title  ICMJE Open-label, Randomized, Single-Dose, 2 Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet
Brief Summary To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.
Detailed Description Not 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 Anxiety Disorder
Intervention  ICMJE
  • Drug: Alprazolam tablet
    1 mg single dose of alprazolam conventional tablet
  • Drug: Alprazolam sublingual
    1 mg single dose of alprazolam sublingual tablet
Study Arms  ICMJE
  • Active Comparator: Alprazolam conventional tablet
    Alprazolam conventional tablet
    Intervention: Drug: Alprazolam tablet
  • Experimental: Alprazolam sublingual tablet
    Alprazolam sublingual tablet
    Intervention: Drug: Alprazolam sublingual
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 Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2010)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
  • Signed informed consent.

Exclusion Criteria:

  • Evidence or history of clinically significant abnormalities
  • Positive drug screen, excessive alcohol and tobacco use
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01256151
Other Study ID Numbers  ICMJE A6131024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP