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

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline; Drug: Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.

• Registration Number: NCT00864981
• Lead Sponsor: Sandoz

Brief Summary

The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 150 mg SR Tablets under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2009-03
• Study First Submitted: 2009-03-13
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 or C.
• Treatment for drug or alcohol dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline	WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg
1	Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.	Bupropion HCI ER Tablets, 150 mg

Primary Outcome Measures

Name	Time	Method
Bioequivalence according to US FDA timelines	29 days