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Bupropion HCI EON

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 Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Bupropion HCI EON · 1 trial · 1 indication

Phase 1 1
NCT00861939To Demonstrate the Relative Bioavailability of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting ConditionsDepression
COMPLETED28 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions
Depression
NCT0086193928
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Study Endpoints

Primary Endpoints

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

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBupropion HCl 300mg Extended Release Tablet
2ACTIVE_COMPARATORWELLBUTRIN XL 300mg Tablets

Interventions

NameTypeDescription
Bupropion HCI 300 mg Extended-Release Tablets EONDRUG -
WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKlineDRUG -
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Eligibility Criteria

Age Range18 Years to 58 Years
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 orc. * Treatment for drug or alcohol dependence.

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