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A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Fasting Conditions

NCT01188031 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-08-25

No results posted yet for this study

Summary

This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2 mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult volunteers administered under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG

A: Experimental Subjects received Purepac Pharmaceutical Co. formulated products under fasting conditions

DRUG

NIRAVAM TM 2 mg orally disintegrating tablets, single dose

B: Active comparator Subjects received Schwarz Pharma Inc. 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
2006-06-30
Primary Completion
2006-07-31
Completion
2006-07-31

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 NCT01188031 on ClinicalTrials.gov