To Demonstrate the Relative Bioavailability of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: Bupropion HCI 300 mg Extended-Release Tablets EON; Drug: WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline

• Registration Number: NCT00861939
• Lead Sponsor: Sandoz

Brief Summary

The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 300 mg ER Tablets under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Status Verified: 2009-03
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria

• Positive test results for HIV or hepatitis B orc.
• Treatment for drug or alcohol dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Bupropion HCI 300 mg Extended-Release Tablets EON	Bupropion HCl 300mg Extended Release Tablet
2	WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline	WELLBUTRIN XL 300mg Tablets

Primary Outcome Measures

Name	Time	Method
Bioequivalence according to US FDA timelines	17 days