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NCT01046162 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01046162
Other study ID # A6131021
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date July 15, 2010
Est. completion date July 22, 2010

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 22, 2010
Est. primary completion date July 22, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Alprazolam
Single tablet
• Alprazolam
Single tablet

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.

Outcome
Type Measure Description Time frame Safety issue
Primary Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-8) of the two formulations of Alprazolam. 10 days
Primary Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence. 10 days
Secondary Investigate the safety of both preparations based on the record of adverse events on completing both study periods. 10 days
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