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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01046162
Recruitment Status : Withdrawn
First Posted : January 11, 2010
Last Update Posted : August 6, 2010
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Alprazolam Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : July 2010
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Tafil Tablets 2 mg Pharmacia Upjohn Drug: Alprazolam
Single tablet
Other Name: Tafil Pharmacia Upjohn
Active Comparator: Xanax Tablets 2 mg Pfizer LLC Drug: Alprazolam
Single tablet
Other Name: Xanax Pfizer

Primary Outcome Measures :
  1. 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 ]
  2. Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence. [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Investigate the safety of both preparations based on the record of adverse events on completing both study periods. [ Time Frame: 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01046162

Sponsors and Collaborators
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01046162     History of Changes
Other Study ID Numbers: A6131021
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: August 6, 2010
Last Verified: August 2010

Keywords provided by Pfizer:
Drug Kinetics

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action