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This study has been withdrawn prior to enrollment.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:
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01046162
First received: January 7, 2010
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Healthy
Drug: Alprazolam
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 26
Study Start Date: July 2010
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046162

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01046162     History of Changes
Other Study ID Numbers: A6131021
Study First Received: January 7, 2010
Last Updated: August 5, 2010
Health Authority: Mexico: Ministry of Health

Keywords provided by Pfizer:
Alprazolam
Tafil
Xanax
Bioequivalence
Drug Kinetics

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

ClinicalTrials.gov processed this record on July 26, 2014