Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bupropion XL · 2 trials · 1 indication
Blood sample will be collected at pre-dosing, and 2, 3, 4, 5, 6, 8, 12, 16, and 24 hour (h) post dose.
Blood sample will be collected at pre-dosing, and 2, 3, 4, 5, 6, 8, 12, 16, and 24 h post dose.
Blood sample will be collected at pre-dosing, and 2, 3, 4, 5, 6, 8, 12, 16, and 24 h post dose.
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively. Blood sample will be also collected at pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after 300 mg dose (Day 14 to 19).
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12 h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12 h post dose after last 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12 h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
| Arm | Type | Description |
|---|---|---|
| Bupropion XL once daily | EXPERIMENTAL | Healthy subjects will receive Bupropion XL 150milligram (mg) once daily for 5 days (Day 1 to Day 5) and then Bupropion XL 300 mg once daily from Day 6 to Day 14. |
| Name | Type | Description |
|---|---|---|
| bupropion XL | DRUG | - |
| Bupropion HCl XL tablet 150mg | DRUG | The 150 mg of tablet will be given to subject once daily orally. Subject will be instructed to swallow whole tablet with 240 ml of water, without crushed, divided or chewed. |
| Bupropion HCl XL tablet 300mg | DRUG | The 300 mg of tablet will be given to subject once daily orally. Subject will be instructed to swallow whole tablet with 240 ml of water, without crushed, divided or chewed. |
Inclusion Criteria: * Primary diagnosis of Major Depressive Disorder with DSM-IV criteria for their current episode for at least 8 weeks. Exclusion Criteria: * Patient has current or past history of seizure disorder or brain injury. * Patient has a diagnosis of anorexia or bulimia within the past...
Bupropion XL is an extended-release oral tablet being studied for major depressive disorder. It is a small molecule developed by GSK plc under the ticker GSK. The clinical program includes a Phase 3 trial in elderly patients with major depressive disorder and a Phase 1 pharmacokinetic study in healthy Chinese volunteers.
Bupropion XL targets SLC6A3 and SLC6A2, which are the dopamine transporter and the norepinephrine transporter. It acts as an inhibitor of these transporters. This target profile distinguishes it from many other antidepressants that act primarily on serotonin pathways.
Bupropion XL is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor behind the clinical development program for the extended-release tablet formulation in major depressive disorder.
Bupropion XL has reached Phase 3 development. The Phase 3 trial NCT00093288 evaluated the drug in elderly patients with major depressive disorder and has completed. A Phase 1 pharmacokinetic study, NCT02698553, has also completed. No trials are currently listed as active.
Bupropion XL has been studied in two completed trials. NCT00093288 was a Phase 3 trial in major depressive disorder in the elderly, enrolling 364 patients across Australia, Belgium, Finland, Netherlands, Norway and Russia. NCT02698553 was a Phase 1 pharmacokinetic, safety and tolerability study in 16 healthy Chinese volunteers.