BUPROPION HYDROCHLORIDE

Post-LOE

bupropion hydrochloride

ANDAORALTABLET, EXTENDED RELEASE
Approved
Mar 2016
Lifecycle
Post-LOE
Competitive Pressure
30/100
Clinical Trials
3

Mechanism of Action

known, but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine, and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.

Clinical Trials (3)

NCT02698553Phase 1Completed

A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Extended-release Bupropion Hydrochloride Tablets in Chinese Healthy Volunteers

Started May 2016
16 enrolled
Depressive Disorder, Major
NCT02191397Phase 3Completed

Study to Evaluate the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release Tablet, and Escitalopram Oxalate Capsule in Subjects With Major Depressive Disorder

Started Feb 2015
534 enrolled
Depressive Disorder, Major
NCT01046214Phase 1Terminated

Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions

Started Jan 2010
8 enrolled
Depressive Disorder