Clinical Study of Generic and Brand Bupropion in Depression

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Bupropion XL 300

• Registration Number: NCT02209597
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.

Detailed Description

The protocol is a prospective, randomized, double-blinded, crossover study with Major Depressive Disorder (MDD) receiving bupropion HCl 300mg XL (branded or generic).

Subjects will be studied in 4 phases for a total of approximately 28 weeks:

Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).

Study Timeline

• Study Start: 2014-06-25
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-06
• Primary Completion: 2016-08-14
• Study Completion: 2016-08-14
• Results First Submitted: 2018-06-20
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-23
• Last Update Submitted: 2020-04-23
• Results First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
StudyArm	Bupropion XL 300	Subjects will be studied for 28 weeks in a sequential cross-over study: a Subjects will be studied in 4 phases for a total of approximately 28 weeks: Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion	For 24 hours approximately every 6 weeks	Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States