Bioequivalence of Alprazolam Sublingual vs Oral Tablets

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00860119
First received: March 10, 2009
Last updated: November 11, 2009
Last verified: November 2009

March 10, 2009
November 11, 2009
August 2009
October 2009   (final data collection date for primary outcome measure)
Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax) [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00860119 on ClinicalTrials.gov Archive Site
  • Alprazolam time of maximum concentration (Tmax) and half life [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Adverse events, clinical laboratory tests, vital signs [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00860119
A6131017
No
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