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A Relative Bioavailability Study of Alprazolam 3 mg ER Tablets Under Fasting Conditions

NCT00865761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-08-17

No results posted yet for this study

Summary

The purpose of this study is to compare the relative bioavailability of 3 mg Alprazolam Extended Release Tablets by Alpharma with that of 3 mg XANAX XR® Tablets by Pharmacia \& Upjohn Company following a single oral dose (1 x 3 mg extended-release tablet) in healthy adult volunteers administrated under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Alprazolam 3 mg Extended Release Tablets, single dose

A: Experimental Subjects received Alpharma formulated products under fasting conditions

DRUG

XANAX XR® 3 mg tablets, single dose

B: Active comparator Subjects received Pharmacia \& Upjohn Company formulated products under fasting conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • James D. Carlson,, Pharm.D, · PRACS Institute, Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00865761 on ClinicalTrials.gov