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Bupropion HCI, EON Labs Inc

Phase 1

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

Target and mechanism

Molecular targetSLC6A3, SLC6A2
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL894

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
DepressionUnlock trial analytics

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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Frequently asked questions about Bupropion HCI, EON Labs Inc

What is Bupropion HCI, EON Labs Inc?

Bupropion HCI, EON Labs Inc is an extended-release tablet formulation of bupropion hydrochloride, 150 mg, developed by Novartis AG (ticker NVS). It is a small molecule in the psychiatry therapeutic area, studied for depression. The product is also known as Bupropion HCI ER Tablets, 150 mg; EON Labs Inc.

What is Bupropion HCI, EON Labs Inc used for?

Bupropion HCI, EON Labs Inc is used for depression. It is an extended-release tablet formulation of bupropion hydrochloride, 150 mg, developed by Novartis AG (NVS). The clinical program in this dataset includes a relative bioavailability study in healthy adult volunteers under fasting conditions.

What does Bupropion HCI, EON Labs Inc target?

Bupropion HCI, EON Labs Inc targets SLC6A3 and SLC6A2. It is an inhibitor of these transporters. SLC6A3 is the dopamine transporter and SLC6A2 is the norepinephrine transporter. This mechanism is consistent with its development for depression by Novartis AG (NVS).

Who makes Bupropion HCI, EON Labs Inc?

Bupropion HCI, EON Labs Inc is developed by Novartis AG, which trades under the ticker NVS. The product is an extended-release tablet formulation of bupropion hydrochloride, 150 mg, and is listed in the psychiatry therapeutic area for depression.

What phase is Bupropion HCI, EON Labs Inc in?

Bupropion HCI, EON Labs Inc is in Phase 1 development. The program includes one completed Phase 1 trial. It is investigational and is not described as approved. The trial was a relative bioavailability study of the 150 mg sustained-release tablets under fasting conditions.

What clinical trials is Bupropion HCI, EON Labs Inc in?

Bupropion HCI, EON Labs Inc has been studied in one completed Phase 1 trial, NCT00864981, titled A Relative Bioavailability Study of Bupropion HCI 150 mg Sustained-Release Tablets Under Fasting Conditions. It enrolled 32 healthy adult volunteers, was randomized, and used an active-controlled design.