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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01046162

Collaborator

Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V. (Other)

Enrollment

Arms

Anticipated Duration (Days)

Study Details

Study Description

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 Drug: Alprazolam	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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 (r), Product Of Pharmacia& Upjohn S.a De C.v Vs Xanax 2mg, Product Of Pfizer Pharmaceuticals Llc) In Healthy Volunteers In Fasting Conditions

Actual Study Start Date :

Jul 15, 2010

Anticipated Primary Completion Date :

Jul 22, 2010

Anticipated Study Completion Date :

Jul 22, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Tafil Tablets 2 mg Pharmacia Upjohn

Drug: Alprazolam

Single tablet

Other Names:

Tafil Pharmacia Upjohn

Active Comparator: Xanax Tablets 2 mg Pfizer LLC

Drug: Alprazolam

Single tablet

Other Names:

Xanax Pfizer

Outcome Measures

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. [10 days]
Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence. [10 days]

Secondary Outcome Measures

Investigate the safety of both preparations based on the record of adverse events on completing both study periods. [10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

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