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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: Alprazolam
  • Single tablet
• Drug: Alprazolam
  • Single tablet

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Tafil Tablets 2 mg Pharmacia Upjohn
• Active Comparator: Xanax Tablets 2 mg Pfizer LLC

Primary 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.
  • Time Frame: 10 days
    Safety Issue?: No
• Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence.
  • Time Frame: 10 days
    Safety Issue?: No

Secondary Measures

• Investigate the safety of both preparations based on the record of adverse events on completing both study periods.
  • Time Frame: 10 days
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01046162

Study ID Number: A6131021

ClinicalTrials.gov Identifier: NCT01046162

Health Authority: Mexico: Ministry of Health

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