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A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Centro de Investigacion Farmacologica y Biofarmaceutica SA de CV
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01046162
First received: January 7, 2010
Last updated: August 5, 2010
Last verified: August 2010
History of Changes

January 7, 2010
August 5, 2010
July 2010
July 2010   (final data collection date for primary outcome measure)
  • Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Alprazolam. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01046162 on ClinicalTrials.gov Archive Site
Investigate the safety of both preparations based on the record of adverse events on completing both study periods. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions
An Open Label, Crossover, Randomized Study of Two Periods, Two Treatments, Two Sequences, and a Single Dose of Two Oral Drug Products of Alprazolam 2mg (Tafil ® 2 mg, Product of Pharmacia & Upjohn SA de CV vs Xanax ® 2 mg, Product of Pfizer Pharmaceuticals LLC) in Healthy Volunteers in Fasting Conditions

The purpose of this study is to compare bioavailability between formulations of alprazolam in tablets to determine their bioequivalence in terms of rate and magnitude of absorption.
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
    Single tablet
    Other Name: Tafil Pharmacia Upjohn
  • Drug: Alprazolam
    Single tablet
    Other Name: Xanax Pfizer
  • Active Comparator: Tafil Tablets 2 mg Pharmacia Upjohn
    Intervention: Drug: Alprazolam
  • Active Comparator: Xanax Tablets 2 mg Pfizer LLC
    Intervention: Drug: Alprazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
26
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers (male or female)
  • Age between 18-40 years
  • body mass index (Quetelet´s index) between 18-27

Exclusion Criteria:

  • Unhealthy subjects
  • Volunteers who require any medication over the course of the study
  • Volunteers who have received investigational drugs within 60 days prior to the study
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01046162
A6131021
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Centro de Investigacion Farmacologica y Biofarmaceutica SA de CV
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

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