A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedStudy Start
First participant enrolled
July 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2010
CompletedJanuary 28, 2021
January 1, 2021
7 days
January 7, 2010
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Investigate the safety of both preparations based on the record of adverse events on completing both study periods.
10 days
Study Arms (2)
Tafil Tablets 2 mg Pharmacia Upjohn
ACTIVE COMPARATORXanax Tablets 2 mg Pfizer LLC
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers (male or female)
- Age between 18-40 years
- body mass index (Quetelet´s index) between 18-27
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2010
First Posted
January 11, 2010
Study Start
July 15, 2010
Primary Completion
July 22, 2010
Study Completion
July 22, 2010
Last Updated
January 28, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests