Clinical trial • Phase III • Psychiatry
Bupropion hydrochloride for Seasonal affective disorder | Major depressive disorder
Phase III trial of Bupropion hydrochloride for Seasonal affective disorder | Major depressive disorder.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Seasonal affective disorder | Major depressive disorder
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-01-2026
- First CTIS Authorization Date
- 05-05-2026
Trial design
Randomised, open-label, three-treatment, three-period, three-sequence crossover comparing the test product (bupropion hydrochloride extended release capsules 150 mg, single dose) under different administration conditions including food and apple sauce (details of comparator conditions/schedules not fully specified).-controlled, crossover Phase III trial across 1 site in Romania.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Three-treatment, three-period, three-sequence crossover comparing the Test product (Bupropion Hydrochloride Extended Release Capsules 150 mg, single dose) under different administration conditions including food and apple sauce (details of comparator conditions/schedules not fully specified).
- Crossover
- Yes
- Target Sample Size
- 72
Eligibility
Recruits 72 Vulnerable population selected (isVulnerablePopulationSelected: true); no details on consent or assent provided in the available documentation..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true); no details on consent or assent provided in the available documentation.
Recruitment
- Planned Sample Size
- 72
- Recruitment Window Months
- 4
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 72
Romania
- Earliest CTIS Part Ii Submission Date
- 18-03-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 48
- Number Of Sites
- 1
- Number Of Participants
- 72
Sites
- Site Name
- Terapia S.A.
- Department Name
- Clinical Pharmacology and Pharmacokinetics
- Contact Person Name
- Elena Timofte
- Contact Person Email
- Elena.Timofte@sunpharma.com
- Number Of Participants
- 72
Sponsor
Primary sponsor
- Full Name
- Sun Pharmaceutical Industries Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- India
Investigational products
- Investigational Product Name
- Bupropion Hydrochloride Extended Release Capsules 150 mg (Test product, manufactured by Sun Pharmaceutical Industries Limited, India)
- Active Substance
- Bupropion hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Oral (capsule)
- Route
- Oral
- Starting Dose
- 150 mg
- Dose Levels
- 150 mg single dose
- Frequency
- Single dose
- Maximum Dose
- 150 mg
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