At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 74 enrolled
Drug / intervention
Bupropion XL 300drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bioequivalence and Clinical Effects of Generic and Brand Bupropion
In Brief
A Phase 4 clinical trial evaluating Bupropion XL 300 for Major Depressive Disorder. Completed, enrolled 74 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
First PostedAug 2014
Primary CompletionAug 2016
TodayJul 2026
First PostedAug 6, 2014
Enrollment StartJun 25, 2014
Primary CompletionAug 14, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.9 years ago
Interventions
Bupropion XL 300drug
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).