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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-15

Study Completion Date

2010-07-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tafil Tablets 2 mg Pharmacia Upjohn

Group Type ACTIVE_COMPARATOR

Alprazolam

Intervention Type DRUG

Single tablet

Xanax Tablets 2 mg Pfizer LLC

Group Type ACTIVE_COMPARATOR

Alprazolam

Intervention Type DRUG

Single tablet

Interventions

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Alprazolam

Single tablet

Intervention Type DRUG

Alprazolam

Single tablet

Intervention Type DRUG

Other Intervention Names

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Tafil Pharmacia Upjohn Xanax Pfizer

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes