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Bupropion HCI, EON Labs Inc

Phase 1

Depression | Small molecule | Psychiatry |Novartis AG|Last Updated: Mar 29, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Bupropion HCI, EON Labs Inc · 1 trial · 1 indication

Phase 1 1
NCT00864981A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting ConditionsDepression
COMPLETED32 Analytics
PHASE1COMPLETED
A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions
Depression
NCT0086498132
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Study Endpoints

Primary Endpoints

Bioequivalence according to US FDA timelines
29 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBupropion HCI ER Tablets, 150 mg
2ACTIVE_COMPARATORWELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg

Interventions

NameTypeDescription
Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.DRUG -
WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKlineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

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.

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