NCT00865111

A Relative Bioavailability Study of Bupropion Sustained Release 150 mg Tablets Under Fasting Conditions

A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Sustained Release Tablets in Fasted, Normal, Healthy Men.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion 150 mg sustained release tablet to that of Wellbutrin SR sustained release tablet after a single, one-tablet dose in fasted subjects.

Detailed description

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design. Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Sustained Release Tablets in Fasted, Normal, Healthy Men. Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Bupropion 150 mg Extended-Released Tablet, single dose	A: Experimental Subjects received Abrika formulated products under fasting conditions
DRUG	Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose	B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2009-03-19
• Last updated: 2010-08-16

Locations

1 site across 1 country: United States