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

Viatris

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: Alprazolam

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01046162

A6131021

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Tafil Tablets 2 mg Pharmacia Upjohn

Active Comparator group

Treatment:

Drug: Alprazolam

Drug: Alprazolam

Xanax Tablets 2 mg Pfizer LLC

Active Comparator group

Treatment:

Drug: Alprazolam

Drug: Alprazolam