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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Nabumetone 750 mg tablets, single dose

• Registration Number: NCT00864968
• Lead Sponsor: Actavis Inc.

Brief 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.

Detailed Description

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

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

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2009-03-18
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-13
• Last Update Posted: 2010-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Nabumetone 750 mg tablets, single dose	Nabumetone 750 mg tablets, single dose
B	Nabumetone 750 mg tablets, single dose	Nabumetone 750 mg tablets, single dose

Primary Outcome Measures

Name	Time	Method
Rate and Extend of Absorption	120 hours

Trial Locations

Locations (1)

AAIPharma Inc., AAI Clinic; 🇺🇸 Morrisville, North Carolina, United States