NCT01046214

Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

A Multiple-Dose, Double Blind, Double Dummy, Comparative Bioavailability Study of Two Formulations of Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the comparative bioavailability between bupropion hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL® 300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients under fasting conditions.

Conditions

• Depressive Disorder

Interventions

Type	Name	Description
DRUG	Bupropion HCl	Budeprion XL™ 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the reference-placebo tablet
DRUG	Bupropion HCl	Wellbutrin XL® 300 mg Extended Release Tablet dosed once daily for 8 days, in the morning, after an overnight fast of at least 10 hours, with the test-placebo tablet

Timeline

• Start date: 2010-01-01
• First posted: 2010-01-11
• Last updated: 2015-11-20

Locations

2 sites across 1 country: United States