Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01285505
First received: January 26, 2011
Last updated: April 7, 2011
Last verified: April 2011

January 26, 2011
April 7, 2011
April 2011
June 2011   (final data collection date for primary outcome measure)
  • Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC) [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Alprazolam bioavailability as assessed by peak concentration (Cmax) [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01285505 on ClinicalTrials.gov Archive Site
  • Alprazolam time of maximum concentration (Tmax) [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Half life of alprazolam [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • Clinically significant safety laboratory tests [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
  • Clinically significant adverse events [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
  • Clinically significant vital signs [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01285505
A6131020
No
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