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

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: Alprazolam

• Registration Number: NCT01046162
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Study Start: 2010-07-15
• Primary Completion: 2010-07-22
• Study Completion: 2010-07-22
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Xanax Tablets 2 mg Pfizer LLC	Alprazolam	-
Tafil Tablets 2 mg Pharmacia Upjohn	Alprazolam	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Investigate the safety of both preparations based on the record of adverse events on completing both study periods.	10 days