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Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers

NCT00864968 · 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 evaluate the relative bioavailability of nabumetone from 2 tablet products and determine if the 2 products were bioequivalent to each other.

Conditions

  • Healthy

Interventions

DRUG

Nabumetone 750 mg tablets, single dose

A: Experimental Subjects received Actavis Elizabeth LLC formulated products under fasting conditions

DRUG

Nabumetone 750 mg tablets, single dose

B: Active comparator Subjects received Teva formulated products under fasting conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Evin H. Sides III, M.D. · AAIPharma Inc., AAI Clinic

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-03-31
Completion
2007-03-31

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 NCT00864968 on ClinicalTrials.gov