NCT00865410

A Relative Bioavailability Study of Bupropion Extended-Released 150 mg Tablets Under Fasting Conditions

A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study of Bupropion Extended-Released Tablets Formulation in Fasted, Normal, Healthy Subjects.

• 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 Bupropion HCl extended-release tablet (test) to that of Wellbutrin SR extended-release tablet (reference) after a single, one-tablet (150 mg) 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 Extended-Released Tablets Formulation in Fasted, Normal, Healthy Subjects. Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2004-08-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2009-03-19
• Last updated: 2010-08-16

Locations

1 site across 1 country: United States