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A double blinded, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study comparing Bupropion Hydrochloride Sustained-Release Tablets 150 mg, manufactured for Sun Pharmaceutical Industries Limited, India with PrOdan Bupropion SR (Bupropion Hydrochloride Sustained-Release Tablets 150 mg), product of Odan Laboratories Ltd., 325 Stillview Avenue, Pointe Claire, Quebec, H9R 2Y6, in healthy adult, human subjects under fed condition.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516035-27-00
Acronym
BUPRO-08-24
Enrollment
56
Registered
2025-10-27
Start date
2026-01-09
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major depressive illness

Interventions

None listed

Sponsors

Sun Pharmaceutical Industries Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026