NCT00863941

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the rate and extent of absorption of Abrika Bupropion 150 mg XL Tablet to that of Wellbutrin XL® 150 mg 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 XL 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 XL Tablet, single dose	A: Experimental Subjects received Abrika formulated products under fasting conditions
DRUG	Wellbutrin XL® 150 mg Tablet, single dose	B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions

Timeline

• Start date: 2004-06-01
• Primary completion: 2004-07-01
• Completion: 2004-07-01
• First posted: 2009-03-18
• Last updated: 2010-08-23

Locations

1 site across 1 country: United States