NCT02698553

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

An Open-label, Fixed Sequence Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Repeated Dose of Extended-release Bupropion Hydrochloride (Bupropion XL) Tablets 150 mg and 300 mg Once Daily in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Bupropion is used in psychological disorder mainly in major depressive disorder (MDD). In China, buproprion Immediate Release (IR) and Sustained Release (SR) tablet have been in market for the treatment of MDD. Bupropion Hydrochloride (HCl) Extended Release (XL) tablets formulation is proposed for marketing approval in China for same indication. Therefore, a pharmacokinetic study is planned to be conducted in Chinese subjects. It is an open label, single-centre and single cycle study to evaluate the pharmacokinetics, safety and tolerability of 150 milligram (mg) and 300 mg following single and repeated daily doses. Approximately 16 males and females Chinese healthy subjects will be enrolled into the study to get 12 completed subjects.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Bupropion HCl XL tablet 150mg	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.
DRUG	Bupropion HCl XL tablet 300mg	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.

Timeline

• Start date: 2016-05-23
• Primary completion: 2016-06-29
• Completion: 2016-06-29
• First posted: 2016-03-03
• Last updated: 2018-09-13

Locations

1 site across 1 country: China