2024-518211-20-00CompletedPhase 1
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutamide film coated tablets 160 mg, Manufactured for Sun Pharmaceutical Industries Limited, India with XTANDI (Enzalutamide) 80 mg film coated tablets, Made by: Patheon Inc., 2100 Syntex Court, Mississauga, Ontario – Canada, Imported and registered by: Astellas Farma Brasil Importação e Distribuição de Medicamentos Ltda., São Paulo-SP, Brazil, in healthy adult, male subjects under fasting condition.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Apr 2025
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 29 Nov 2024
- Start date
- 14 Apr 2025
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- EU CT number
- 2024-518211-20-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 40
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Terapia S.A. | Cluj-Napoca | Romania | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.