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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Alprazolam (Drug); Alprazolam (Drug)

Phase: Phase 1

Status: Withdrawn

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

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.

Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence.

Secondary outcome: Investigate the safety of both preparations based on the record of adverse events on completing both study periods.


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2010
Last updated: August 5, 2010

Page last updated: August 23, 2015

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