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Bupropion HCI EON · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Bupropion HCl 300mg Extended Release Tablet |
| 2 | ACTIVE_COMPARATOR | WELLBUTRIN XL 300mg Tablets |
| Name | Type | Description |
|---|---|---|
| Bupropion HCI 300 mg Extended-Release Tablets EON | DRUG | - |
| WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline | DRUG | - |
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.
Bupropion HCI EON is an extended-release tablet formulation of bupropion hydrochloride developed by Novartis AG under the ticker NVS. It is a small molecule being studied in a Phase 1 clinical program for depression. The product is also known as Bupropion HCI 300 mg Extended-Release Tablets EON.
Bupropion HCI EON is being developed for the treatment of depression. It is an extended-release tablet formulation containing 300 mg of bupropion hydrochloride. The clinical program is in Phase 1, so the drug remains investigational and has not been approved for commercial use.
Bupropion HCI EON targets the dopamine transporter SLC6A3 and the norepinephrine transporter SLC6A2. It acts as an inhibitor of these transporters. This mechanism is consistent with its development for depression, where modulation of dopamine and norepinephrine signaling is relevant.
Bupropion HCI EON is developed by Novartis AG, which trades under the ticker NVS. Novartis is responsible for the clinical development of this extended-release bupropion hydrochloride formulation.
Bupropion HCI EON is in Phase 1 clinical development. The program includes one completed Phase 1 trial. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
Bupropion HCI EON has been evaluated in one completed Phase 1 trial, NCT00861939. The study was titled "To Demonstrate the Relative Bioavailability of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions." It enrolled 28 healthy adult volunteers, was randomized, and used an active-controlled design.