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Wellbutrin

Phase 1

Healthy | Small molecule | Other |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 Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Wellbutrin · 1 trial · 1 indication

Phase 1 1
NCT00883155To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting ConditionsHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
29 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBupropion HCl 100 mg Tablets (Invamed Inc.)
2ACTIVE_COMPARATORWellbutrin 100 mg Tablets (Glaxo Wellcome)

Interventions

NameTypeDescription
Bupropion HCl 100 mg Tablets (Invamed Inc.)DRUG -
Wellbutrin 100 mg Tablets (Glaxo Wellcome)DRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
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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Frequently asked questions about Wellbutrin

What is Wellbutrin used for?

Wellbutrin is an investigational small molecule being studied in healthy volunteers. It is being developed by Novartis AG. The drug is currently in Phase 1 clinical development, with one completed trial evaluating its relative bioavailability under fasting conditions.

Who makes Wellbutrin?

Wellbutrin is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.

What phase is Wellbutrin in?

Wellbutrin is in Phase 1 clinical development. It has one completed Phase 1 trial, NCT00883155, which evaluated the relative bioavailability of bupropion HCl 100 mg tablets under fasting conditions in 36 healthy male volunteers. The drug is not yet approved and remains investigational.

What clinical trials is Wellbutrin in?

Wellbutrin has one completed clinical trial, NCT00883155, titled 'To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions.' This Phase 1 study enrolled 36 healthy male volunteers aged 18 years and older and was active-controlled.

Is Wellbutrin FDA approved?

Wellbutrin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial, NCT00883155, was a bioavailability study in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory approval.